Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Lymphatic Metastasis

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Parasympatholytics

Participants will undergo one MRI examination of approximately 45 minutes including an intramuscular injection with an antispasmodic agent to minimize bowel movement

MRI examination of the prostate

Carlijn Tenbergen

Tom Scheenen, Prof. Dr.

Tom Scheenen

The primary aim of this study is to assess the potential of quantitative MRI measurements to predict localized prostate cancer T-stage and disease spread to nodes (N-stage) by correlating quantitative MRI measurements of the local prostate to the presence of metastases as seen on PSMA-PET/CT.

Patients diagnosed with prostate cancer will likely not die from the primary tumor, but from (extended) metastatic disease. One of the first steps towards extended metastatic disease is the presence of lymph node metastases, which is an important factor in determining therapy and prognosis. Although historically all patients with lymph node metastases are considered incurable, research has shown that patients with only a limited number of small (\<8 mm) nodal metastases have a better prognosis as compared to patients with more extensive involvement. In patients with only a limited number of small nodal metastases (oligo-metastatic), therapy with curative intent might be pursued, e.g. by surgical resection or loco-regional radiotherapy. With continuously improving opportunities to very selectively treat small numbers of metastatic sites it is of utmost importance to accurately diagnose the first signs of oligo-metastatic disease and to define its extent.

It is hypothesized that magnetic resonance imaging (MRI) can obtain more information from the local prostate than what is now used in the clinic to stage localized prostate cancer and oligo-metastatic disease. In recent years positron emission tomography (PET) in combination with computerized tomography (CT) and Prostate Specific Membrane Antigen (PSMA) tracers (PSMA-PET/CT) has emerged as an imaging modality to visualize (early) metastatic disease, but its accuracy in detecting oligo-metastatic spread is unknown, as small nodal metastases can be missed. In this study, the correlation is assessed between functional, quantitative and metabolic local tumor characteristics with PSMA-PET/CT-proven nodal involvement, to be able to predict metastatic potential from quantitative MRI parameters of the localized tumor. If the study shows potential for predicting presence of metastatic disease, future patients will benefit from improved nodal staging, potentially leading to more accurate and personalized treatment of the correct disease stage.

Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer

To find the optimal combination of quantitative parameters for discriminating between positive and negative PSMA-PET/CT, logistic regression modelling will be used. The performance of the model will be evaluated using receiver operating characteristic curve analysis.

To test the individual quantitative MRI parameters for a significant difference between localized and (oligo-)metastatic disease, non-parametric tests for independent groups (Mann-Whitney U test) will be used. The ability of each parameter to discriminate between positive and negative PSMA-PET/CT is assessed using receiver operating characteristic curve analysis, which allows comparison to the logistic regression model performance.

Participants with a positive PET/CT scan result will be divided in groups according to the number of positive lymph nodes detected (if variance within participants allows). To test for significant differences between these groups for each of the quantitative parameters, the non-parametric tests for multiple independent groups (Kruskal Wallis) will be used.

To test for a correlation between the quantitative parameters and the local prostate PSMA-PET intensity, a spearmans rho test for correlation between two continuous variables will be used.

Radboud University Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Adenocarcinoma

Lung Neoplasms

Adenocarcinoma of Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Hippocampal-sparing prophylactic cranial irradiation (25 Gy in 10 fractions)

Hippocampal-sparing prophylactic cranial irradiation with 25 Gy in 10 fractions

HS-PCI

Frederik Wenz, MD

Frank A. Giordano, MD

The primary aim of this study is evaluate the impact of hippocampal-sparing prophylactic cranial irradiation (HS-PCI) on survival status in patients with nodal-positive (locally advanced) adenocarcinoma by comparing overall survival rates of patients undergoing HS-PCI to that of patients without this intervention. In addition, this study aims to investigate whether HS-PCI is detrimental on neurocognitive function and to evaluate its impact on the patient's quality of life.

Patients with locally advanced non-small cell lung cancer (LA-NSCLC) have an increased risk of developing central nervous system (CNS) metastases during the course of their disease. The brain is the most common site of failure after first-line therapies (independent of combined sequential or consolidation chemotherapy). Recent studies employing multimodal therapy have reported overall brain metastasis rates ranging from 22% to 55%, and the rates for brain as first site of relapse range from 16% to 43%.

Prophylactic cranial irradiation (PCI) results in a 2-3 fold lower incidence of brain metastasis. However, randomized studies have failed to demonstrate improved overall survival (OS) after PCI.

One of the major weaknesses of these trials is the unselected mixed pool of stage III patients (stage III A and B, lymph node status N0 to N2, squamous and non-squamous histology etc.). A broad variety of studies have shown that a certain subset of patients with NSCLC (e.g. cancers with adenocarcinoma histology, multilevel nodal involvement) are at highest risk for brain metastases. Furthermore, the risk for brain metastases appears to be specifically higher in younger patients (age \<60 years), although this collective commonly undergoes more frequently chemotherapy and/or more aggressive regimens than elderly patients.

Prevention of CNS metastases, even for LA-NSCLC patients with other sites of failure, will improve quality of life and, for patients controlled extracranially, will improve survival. Meta analyses performed on data from several Radiation Treatment Oncology Group (RTOG) studies have shown that longer survival for patients with LA-NSCLC treated with either radiation alone or radiochemotherapy is associated with an increased incidence of CNS metastases. Although the addition of chemotherapy to radiation therapy reduces extracranial distant metastases and improves survival it does not alter brain relapse rates. Even though the addition of modern targeted therapy using small-molecules or antibodies may further improve the outcome, the CNS remains the most common site of failure under targeted therapy, although no evidence for resistance in histological workups of metastases has been found. This emphasizes the urgent need for treatment directed at chemotherapeutically inaccessible (or dormant) micrometastases that are a priori dispersed within the brain. As the median time for relapse in the CNS is approximately 6 months after first-line therapy, the treatment of micrometastases should be meaningfully initiated even during or shortly after first-line therapy.

Irradiation of the brain does not only bear the risk of inducing acute (partially mass-associated) side effects such as nausea, vomiting and fatigue, but also causes long-term neurocognitive deficits. Although neurocognitive disorders after PCI/Whole brain radiotherapy (WBRT) also have a multifactorial etiology based on a patient's individual medical history (preceding chemotherapy, pre-existing vascular damage e.g. from smoking, local reactions/edema), it is currently believed that they are mostly caused by a loss of neural stem cells in the hippocampal areas. Multipotent and self-renewing neural stem cells are found in the subgranular zone of the adult hippocampus and in the subventricular zone of the lateral ventricles. The hippocampus plays an important role in memory consolidation and emotional learning (contextual fear conditioning). The disruption of neurogenesis in the subgranular zone or damage to the hippocampus can lead to impaired short- and long-term memory, learning and contextual fear conditioning. In line with this, irradiating the brain decreases neurogenesis in the hippocampus which leads to impaired hippocampal-dependent learning and memory.

To prevent radiation-induced loss of neuronal stem cells, hippocampus-sparing (HS) radiation techniques have been developed and efficacy has been demonstrated in the recently published phase II RTOG 0933 study. The trial included patients with brain metastases and a Karnofsky Performance Scale (KPS) of 70%. Following HS-WBRT the patients showed a relative neurocognitive function (NCF) decline of 7% four months after HS-WBRT, which is more than four times less than observed in studies with conventional WBRT (30%; p\<0.001).

Since the study was a one-arm study without a control, the reported hippocampal failure rate of 4.5% remains controversially discussed. Multiple studies described the hippocampus and limbic circuit to be a generally rare site of brain metastases in many cancers. NSCLC shows a specifically low rate of hippocampal brain metastasis (2.8% of all brain metastases) and risk modelling revealed a only slightly increased absolute risk (+0.2%) after HS-WBRT. Thus, since in the treatment of NSCLC, the efficient prevention of BM and potential CNS micrometastases is currently outweighed by the associated neurotoxicity and a lack of survival benefit, HS-WBRT may provide a possibility to tip the scale toward prophylactic WBRT, at least for a specific subgroup at high risk.

Radiation regimens for PCI that have influenced patterns of CNS failures in NSCLC have included total doses of 20-36 Gy and fraction sizes of 2-3 Gy. A fraction size of 2 Gy and a total dose of 30 Gy was chosen for the RTOG 0214 study of PCI in LA-NSCLC. This regimen has been shown to decrease CNS metastases from 54% to 13% with no difference in NCF decline in PCI versus non-PCI patients at 4 years. In addition, although there is paucity of clinical data from WBRT with doses in the EQD2 (equivalent dose in 2 Gy fractions) range of 10-20 Gy, a dose-response curve providing a 'best fit' model suggests an only minimal benefit from doses above 30 Gy (EQD2).

HS-PCI in Locally Advanced Adenocarcinoma of the Lung

A Phase III Trial of Hippocampal-sparing Prophylactic Cranial Irradiation (HS-PCI) in Locally Advanced (Stage IIIA/IIIB) Adenocarcinoma of the Lung

Verbal Learning Memory Test (VLMT)

Barthel Activities of Daily Living (ADL) Index

Quality of Life Questionnaires / core and brain module (EORTC-QLQ-C30/BN20)

Universitätsmedizin Mannheim

Director

Infections

Blood and Lymph Conditions

Immune System Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Inflammation

Communicable Diseases

Lymphadenopathy

Sarcoidosis

Neoplasms, Unknown Primary

Pancreatic Neoplasms

Lymphatic Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

the first pass is made with 5ml suction technique

the first pass is made with modified wet suction technique

the first pass is made with 5ml suction technique, then modified wet suction technique / 5ml suction technique/ modified wet suction technique is operated successively.

the first pass is made with modified wet suction technique, then 5ml suction technique/ modified wet suction technique/ 5ml suction technique is operated successively.

Bin Cheng, Doctor

Yun Wang, Doctor

The purpose of this study is to compare the diagnosis accuracy of modified wet suction technique and 5ml dry suction technique on solid occupying lesions.

Patients will be divided into two groups, arm A and arm B according to two different methods adopted in their first needle, which refers to the modified wet suction technique or 5ml dry suction technique.Take the solid occupying lesion diagnosis accuracy as the research major indicator to compare the the modified wet suction technique or 5ml dry suction technique as optimal efficiency test. Take classⅠerror, a=0.05, class II error, β=0.2, power=0.8, suppose that the diagnostic accuracy of dry suction technique to the solid occupying lesions is 75%, the diagnostic accuracy of modified wet suction technique to the solid occupying lesions is 85%, the minimum sample size are 248 patients with 5ml dry suction technique and 248 patients with modified wet suction technique, the 2x2 cross-over design is adopted, namely, each arm has 124 patients respectively. Considering factors including defluxion, 20% cases will be added to two arms, therefore, each arm has 148 patients respectively, the total number of patients is 296.

The statistics experts generated randomized serial numbers（001-296）according to same-size allocation ratio between arm A and arm B with Statistical Analysis System 9.2(SAS 9.2), a statistical software in the randomized block method. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 37 randomized block. One copy send to trial centers for patient allocating, and the another copy be saved by the trial applicant unit. Every trail centers will be responsible for the screening of qualified patients, rank them in visit time to get the randomized grouping number so as to determine them goes to arm A or arm B .The research people and patients in all trial centers should not know the randomized grouping number and relevant arms. The arm name will be sealed under scratch card. Every trial patients will get a unique randomized number, and it will not change through out the whole trial.

Use the inclusion and exclusion criteria to observe the patients and do relative inspections, and confirm if the patients qualified or not to the trial. Record the result of last time test before the treatment. Although it is better to get the informed consent before doing all kinds of observation and tests, if for some reason, the medical imaging examination has completed,as long as the imaging examination was done within 3 weeks before the needle biopsy, it can still be collect as baseline data (imaging examination can be done at other hospitals, but the trial center should issue a new evaluation report 1 week before the patient join the trial group); other lab test items done at 2 weeks before the needle biopsy can still be collect as baseline data for pre-research use, but these tests should be done at the trail center hospital so as to guarantee the data trace ability.

The investigator will puncture the lesion for four needle passes for all of them:For Arm A,5ml dry suction technique is adopted in their first needle, then modified wet suction technique/5ml dry suction technique/modified wet suction technique is operated successively;For Arm B, modified wet suction technique is adopted in their first needle, then 5ml dry suction technique/ modified wet suction technique /5ml dry suction technique is operated successively.Well,the 5ml dry suction technique is conducted as follow:after the needle puncturing into the lesion under ultrasound scanning, remove the stylet and connect the needle to syringe with 5ml negative pressure aspiration, then the needle will be moved to-and-fro within the lesion 20 times. Suction will be released before the needle is withdrawn from the lesion.And the modified wet suction technique is conducted as follow:the needle whose stylet is pulled out will be flushed with 2ml saline solution before puncturing when the lesion has been found, then puncture into the lesions and replace syringe with 5ml negative pressure aspiration, then the needle will be moved to-and-fro within the lesion 20 times. Suction will be released before the needle is withdrawn from the lesion.If no core tissues obtained or the operator determine insufficient specimen according to Macroscopic rapid on-site(MOSE) after the operations above, then remedy procedures will be done, and the punctuation process should be continued with the appropriate punctuation methods until the satisfactory specimens are obtained.Experts in cytology and pathology evaluate the specimen quality and make a diagnosis under the condition that they do not know punctuation methods. The evaluation and diagnosis of each specimen are made by two experts independently. If the two experts hold different opinions, they will make a conclusion after full discussion. If there are two or more cytological smears with same punctuation method, the highest-rate smear should be taken as the standard smear.Follow up (outpatient follow up or telephone follow up) the patients at 1 week, 12 weeks and 36 weeks after the needle biopsy and collect the patients clinical data and confirm their final diagnosis.

Case Report Form(CRF) will be filled by the researchers, every involved patient must have the CRF filled. This will be audited by clinical monitor and handed over to data administrator to input and manage data, the first copy will be kept by the applicant, the second copy will go to the trial center, and the third copy will be kept by the trail researchers.The data input and management will be taken care by specially assigned person. In order to guarantee the data accuracy, data input will be done twice by two independent data administrators, by computerized and manual verifying, hand over the data to statistical experts to do blind check and statistic analyzing.For the questions and doubts within the case report form, the data administrator make DRQ and via the clinical monitor asking the researchers. The researchers will answer and feed back as soon as possible. According to the researchers answer, data administrator will do the data modifying, confirming or inputting, and when necessary send out DRQ again.After blind audition and confirming that the established data base is correct, major researchers, applicant and the statistic analyzing people lock the data. The locked data will not be changed, and the data base will be handed over to statistical analyzer to do the statistic analyze according to the statistic analyzing plan. Problems found after data locking can be modified during the statistic analyzing procedure.This will be done by specialized statistic analyzing people according to the predetermined statistic analyzing plan. The statistic analyze will be carried out according to intention principle confirmed full analysis set and per-protocol set principle. After completing the statistic analyzing, the statistic analyzer issue the statistic analysis report and send this to major researchers to write the study report.

Statistic analyzing plan:（1）General principle①All statistical tests were two-sided. P\<0.05 is regarded that the difference is statistical significance.② Description of quantitative index will calculate the mean and the criteria deviation, description of classification index will describe the number and percentage of each type.（2） Statistical Analysis Method：① For measurement data, compare these data with baseline value during the screening period, adopt the deviation t-test, the variance analysis of cross-over experiment or the rank-sum test of cross-over experiment to make a comparison between these data and baseline value.② For enumeration data, adopt the paired x2-test(including CMH-x2 test) or Fisher's exact test to compare these data of each group.（3）Defluxion Analysis：The total defluxion rate of each group and the defluxion rate caused by adverse events are compared by x2-test or Fisher's exact test.（4）Analysis of baseline value balance：The indexes of some baseline values such as demographic data, vital signs, history of diseases and basic treatment are compared by group t-test and x2 test to measure the balance of each group. Baseline evaluation is made to full analysis set( FAS) and per-protocol set(PPS).（5）Validity Analysis：The primary index of validity analysis is the diagnostic accuracy of the 5ml dry pressure and modified wet pressure to the solid space-occupying lesions. The secondary indexes of validity analysis include the punctuation specimen quality of 5ml dry pressure and modified wet pressure, the diagnostic rate of the first needle of 5ml dry pressure / modified wet pressure and the incidence of complications for modified wet pressure and 5ml dry pressure. The rates of each two arms and Youden indexes are compared by the approximate normal z-test or the central-effect-considered Cochran Mantel Haenszel-x2(CMH-x2 )text.(6)Safety Analysis:The incidences of adverse events/ adverse reactions (including complications from punctuation) of each arm are compared by x2-test or Fisher's exact test and describe the adverse events occurred in this experiment by the list and the normal/abnormal changes of laboratory text results before and after test and the relationship between abnormal changes of laboratory text results and this diagnostic research.(7) All statistical analyses are completed by the professional statistical analysis software, SAS version 9.2.

Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions

Comparing of Modified Wet Suction Technique and Dry Suction Technique for Endoscopic Ultrasound -Guided Fine Needle Aspiration (EUS-FNA) of Solid Occupying Lesions: a Prospective Multi-center,Randomized,and Controlled Trial

The investigators' primary outcome measure is to compare the overall diagnostic accuracy of modified wet suction technique and dry suction technique to the solid occupying lesions.

The investigators'secondary outcome measure is to compare the diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the benign and malignant solid occupying pancreatic lesions and non-pancreatic lesions respectively.

The investigators'secondary outcome measure is to compare the cellularity and blood cell contamination of the solid occupying lesions with modified wet suction technique and 5ml dry suction technique.

Bin Cheng

professor

Ferumoxtran-10 enhanced MRI (MRL)

Jelle Barentsz, Phd MD

This proposal is targeted at all patients with prostate cancer who are candidates for either curative surgery or curative radiotherapy in whom lymph node staging is indicated. Recently, it has been shown, that in patients with PSA \<10 ng/ml and Gleason score \< 7 the risk of lymph node metastases is low. Therefore, unnecessary PLND and non-invasive imaging can be avoided safely in this group. PLND is nowadays performed only in patients with intermediate or high risk for nodal metastases. Thus the subgroup of patients targeted in this study consists of patients with prostate cancer with a PSA \>10 ng/ml and Gleason score \> 6.

* If the high sensitivity (90%) and negative predictive value (96%) of MRL can be validated in the 8 participating centres, in patients with a negative MRL invasive PLND may be avoided.
* In patients with a positive MRL with enlarged nodes (larger than 8 mm) histological diagnosis may be obtained by imaged guided biopsy, and thus also in these patients avoid PLND. A limitation of image guide biopsy, however, is the 30% false negative rate. \[Barentsz, Oyen, Wolf\]
* In patients with positive small nodes (smaller than 8 mm) the urologist may, focussed by the MRL findings of a positive node outside his "surgical field-of-view", extend his dissection, and thus improve his accuracy.
* Based on the expected higher sensitivity of MRL this technique will completely replace CT-scanning.

MR-Lymphography and Lymph Node Staging in Prostate Cancer

MRI With a Lymph Node Specific Contrast Agent: an Alternative for CT-Scanning and Lymph Node Dissection in Patients With Prostate Cancer?

ZonMw: The Netherlands Organisation for Health Research and Development

EUS-FNA (EchoTip Ultra)

EUS-FNB (EchoTip ProCore)

Jinlin Wang, Doctor

The purpose of this study is to compare the diagnosis accuracy of FNA and FNB biopsy on pancreatic, retroperitoneal, mediastinum and pelvic cavity solid occupying lesions.

The study subjects are divided into two groups: the EUS-FNA(22G EchoTip Ultra needles) Group and EUS-FNB group(22G EchoTip ProCore needles).Take the malignant occupying lesion diagnosis accuracy as the research major indicator to compare the EUS-FNB group and EUS-FNA group as optimal efficiency test. Take the class I error a=0.05, class II error β=0.15, power=0.85. Suppose the malignancy diagnosis accuracy is 80%, while that of FNB is 93%. The two trial groups be randomly allocated in 1:1, suppose the malignancy cases take 70% of the whole case, and considering the shedding factors , extra 20% cases should be included. So the estimated cases numbers is 204 cases for EUS-FNB group and 204 cases for EUS-FNA group, totally 408 cases in this trial.

Done by professional statistical people with randomized block grouping method and SAS 9.2 statistical software to generate randomized serial number（001-408）for the two groups in 1:1 manner. The serial numbers are the randomized grouping numbers for the trial patients, block capacity is 8, totally 51 randomized block. The randomized grouping will be generated in duplicate copies and sealed. One copy send to trial centers for patient allocating, and the another copy be saved by the trial applicant unit. Every trail centers will be responsible for the screening of qualified patients, rank them in visit time to get the randomized grouping number so as to determine them goes to the EUS-FNA or EUS-FNB.The research people and patients in all trial centers should not know the the randomized grouping number and relevant groups. The group name will be sealed under scratch card. Every trial patients will get a unique randomized number, and it will not change through out the whole trial.

Use the inclusion and exclusion criteria to observe the patients and do relative inspections, and confirm if the patients qualified or not to the trial. Record the result of last time test before the treatment. Although it is better to get the informed consent before doing all kinds of observation and tests, if for some reason, the medical imaging examination has completed, as long as the imaging examination was done within 3 weeks before the needle biopsy, it can still be collect as baseline data (imaging examination can be done at other hospitals, but the trial center should issue a new evaluation report 1 week before the patient join the trial group); other lab test items done at 2 weeks before the needle biopsy can still be collect as baseline data for pre-research use, but these tests should be done at the trail center hospital so as to guarantee the data trace ability.

The investigators will do the needle passes for 4 times for all of them:the 1-2 needle passes with Slow-Pull and the 3-4 needle passes with Vacuum suction.If no core tissues obtained or the operator/onsite pathologist determine insufficient specimen after the operations above, then remedy procedures will be done, the operator use proper puncture method to continue the remedy biopsy.After the first round of needle biopsy, if the trial patient cannot be diagnosed, by getting the agreement of the patient, the patient will be cross-over to another trial group and do needle biopsy again on the same lesion 1 week later with the method mentioned above.Without knowing the needle biopsy type, the cytologist and pathologist evaluate the specimen quality and make diagnosis. Every specimen will be independently evaluated and diagnosed by 2 experts. If the 2 experts have different judgments, then these two experts discuss together and make the final diagnose discussion. If the same sample has 2 or more cytology smear slides, than take the highest score slide as the result.Follow up (outpatient follow up or telephone follow up) the patients at 1 week, 12 weeks and 36 weeks after the needle biopsy and collect the patients clinical data and confirm their final diagnosis.

During the trial, if severe adverse event occurs, the trialed center must take immediate actions necessary to guarantee the trialed patients' safety. Once severe adverse event occurs, the researchers should inform the trial applicant and the trail center's ethics committee within 24 hours after the researchers gets to know the adverse event. And the researchers should also fax the report to State Food and Drug Administration of China and the local provincial food and drug administration. After receiving the report, the applicant should inform other clinical trial centers within 24 hours. All the severe adverse events should be filed at group leader medical center and other trial centers.

CRF(Case Report Form ) will be filled by the researchers, every involved patient must have the CRF(Case Report Form ) filled. This will be audited by clinical monitor and handed over to data administrator to input and manage data, the first copy will be kept by the applicant, the second copy will go to the trial center, and the third copy will be kept by the trail researchers.The data input and management will be taken care by specially assigned person. In order to guarantee the data accuracy, data input will be done twice by two independent data administrators, by computerized and manual verifying, hand over the data to statistical experts to do blind check and statistic analyzing.For the questions and doubts within the case report form, the data administrator make DRQ and via the clinical monitor asking the researchers. The researchers will answer and feed back as soon as possible. According to the researchers answer, data administrator will do the data modifying, confirming or inputting, and when necessary send out DRQ again.After blind audition and confirming that the established data base is correct, major researchers, applicant and the statistic analyzing people lock the data. The locked data will not be changed, and the data base will be handed over to statistical analyzer to do the statistic analyze according to the statistic analyzing plan. Problems found after data locking can be modified during the statistic analyzing procedure.This will be done by specialized statistic analyzing people according to the predetermined statistic analyzing plan. The statistic analyze will be carried out according to intention principle confirmed full analysis set and per-protocol set principle. After completing the statistic analyzing, the statistic analyzer issue the statistic analysis report and send this to major researchers to write the study report.

Statistic analyzing plan:⑴ General principle:① all the statistic tests are use the two-tailed-test method, P\<0.05 will be thought as the tested difference is statistical significance. ② the quantitative indicator description will calculate the Mean and Standard deviation. The classification indicator description will describe the cases and percentage of all types of cases. ⑵ Statistic analyzing method:① for the measurement data, compare it with the baseline value at selection period, use paired t-test or symbol rank sum test to compare with the before-after-difference within the group.② for the counting data, use x2 test to compare the groups. ⑶ Shedding analysis:Comparison of groups'total shedding rates and the shedding rates caused by adverse events will use x2 test or Fisher's exact test method. ⑷ The baseline value's equilibrium analysis: Use group t test or x2 test to compare the demography info and vital signs, disease history, and basic treatment and other indicators of baseline value, so as to measure the balance of the groups. The baseline evaluation will be done on FAS（full analysis set) and PPs(per-protocol set). ⑸ Effectiveness analysis:The major indicator of effectiveness analysis is the diagnostic accuracy on malignant disease, and the indicators of second effectiveness include the percentage of Grade A specimen and complications rate etc. while the two groups rate and the Youden index comparison will use approximate normal Z test or use central effect x2 test.(6) Safety analysis:Use x2 test or Fisher's exact test to compare the adverse event/adverse reaction (include biopsy complications) rates between the groups. And use table to describe the adverse events during this trial project; the lab test results before and after the trial, the normal/abnormal changing condition and the relationship with this trial research when abnormal changes happened.

Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion

Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB（Endoscopic Ultrasonography-Fine Needle Biopsy ） and EUS-FNA（Endoscopic Ultrasonography-Fine Needle Aspiration ） on Solid Occupying Lesion

The investigators' primary outcome measure is to compare the the diagnostic yield (%) on malignancy of EUS-FNA to EUS-FNB

The amount of blood contamination and cellularity at each sample according to EUS-FNA and EUS-FNB with slow-pull or suction will be measured.

Huazhong University of Science and Technology

Patients (will) undergo radical prostatectomy and pelvic lymph node dissection

Collect pathological slides of resected lymph nodes of the enrolled patients. Digitise these slides into whole-slide images (WSIs). Analyze the WSIs using the AI model to generate diagnostic results (with or without lymphatic metastasis). No intervention to patients would be performed in this diagnostic test study.

Artificial intelligence (AI)-based diagnostic model (developed)

Tianxin Lin, Ph.D

Shaoxu Wu, MD

Cuimei Yao

The goal of this diagnostic test is to prospectively test the performance of pre-developed artificial intelligence (AI) diagnostic model for detecting pathological lymph node metastasis (LNM) of prostate cancer. Investigators had developed this AI model based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.

Investigators will compare the diagnostic performance (sensitivity, specificity, etc.) of the AI model and routine pathological report issued by pathologists, to see if the AI model can improve the clinical workflow of pathological evaluation of LNM in prostate cancer in the real world.

Lymph node metastasis (LNM) is a common mode of metastasis in prostate cancer, and accurate postoperative pathological lymph node staging is of great significance for further treatment and prognosis assessment. However, the current pathological evaluation of lymph nodes relies on manual examination by pathologists, which has a relatively low diagnostic efficiency and is prone to missed-diagnosis for micro metastatic lesions. Therefore, investigators developed an AI diagnostic model for detecting pathological lymph node metastasis of prostate cancer based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.

This study is a diagnostic test with no intervention measures, planning to collect pathological slides of formalin-fixed, paraffin-embedded lymph nodes resected from the enrolled patients and digitise them into whole-slide images (WSIs). The AI model will analyse the WSIs and generate pixel-level heatmaps and slide-level diagnostic results (with or without LNM). The routine pathological examination will be performed as usual. These two processes will not interfere with each other. And if there are inconsistency in slide-level classification between AI and routine pathological examination, investigators would convene senior pathologists for discussion to make the final decision (immunohistochemistry would be performed if necessary). The final result will be presented to the patient in the form of a pathological report.

Histopathological slides of formalin-fixed, paraffin-embedded lymph nodes resected from patients with prostate cancer undergoing radical prostatectomy and pelvic lymph node dissection.

Prospective Validation of Pathology-based Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in Prostate Cancer

To protect patient privacy, pathological slide images and other patient-related data are not publicly accessible.

the number of correctly diagnosed positive slides (with lymphatic metastasis), to be divided by the number of positive slides in total

the number of correctly diagnosed negative slides (without lymphatic metastasis), to be divided by the number of negative slides in total

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Perform conventional sentinel lymph biopsy

Perform radiotherapy instead of sentinel lymph node biopsy

Radiotherapy

The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.

The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.

Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial

A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer

Pain, Discomfort, Numbness, Rotation of arm, Lymphedema of arm

Disease free survival including breast, axilla and other organs from medical record

Ipsilateral axillary lymph nodes from medical record

Other organs except ipsilateral breast and axillary lymph nodes from medical record

No disease on other organs except ipsilateral breast and axillary lymph nodes from medical record

Korean Breast Cancer Study Group

Kyungpook National University Chilgok Hospital

Clinical professor

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Head and Neck Neoplasms

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

prophylactic selective lateral neck dissection

The purpose of this study is to prospectively analyze the incidence of occult lateral neck metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck dissection (SND).

The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore, metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip metastases to the lateral compartment of the neck in the absence of central disease are uncommon.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer	NCT05252806	Prostate Cancer	MRI examination...	50 Years -	Radboud University Medical Center
HS-PCI in Locally Advanced Adenocarcinoma of the Lung	NCT02341170	Lung Cancer Adenocarcinoma Lymphatic Metas...	HS-PCI	18 Years - 75 Years	Universitätsmedizin Mannheim
Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying Lesions	NCT02789371	Pancreas Neopla... Lymphatic Metas... Neoplasm Metast... Unknown Primary... Infection Inflammation Sarcoid Lymphadenopathy	the first pass ... the first pass ...	18 Years - 80 Years	Huazhong University of Science and Technology
MR-Lymphography and Lymph Node Staging in Prostate Cancer	NCT00185029	Prostatic Neopl... Lymphatic Metas...	Ferumoxtran-10 ...	18 Years -	Radboud University Medical Center
MR-Lymphography and Lymph Node Staging in Prostate Cancer	NCT00185029	Prostatic Neopl... Lymphatic Metas...	Ferumoxtran-10 ...	18 Years -	Radboud University Medical Center
Prospective Multi-center, Single Blinded, Randomized, Controlled Trial of EUS-FNB and EUS-FNA on Solid Occupying Lesion	NCT02327065	Pancreas Neopla... Lymphatic Metas... Neoplasm Metast... Unknown Primary...	EUS-FNA (EchoTi... EUS-FNB (EchoTi...	18 Years -	Huazhong University of Science and Technology
Prospective Validation of Pathology-based Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in Prostate Cancer	NCT06253065	Prostatic Neopl... Lymphatic Metas...	Artificial inte...	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Omitting Biopsy of SEntinel Lymph Node With Radiation After Neoadjuvant Chemotherapy in Breast Cancer (OBSERB) Trial	NCT04116125	Breast Neoplasm... Lymphatic Metas...	Radiotherapy	20 Years -	Kyungpook National University Chilgok Hospital
Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer	NCT05252806	Prostate Cancer	MRI examination...	50 Years -	Radboud University Medical Center
Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma	NCT01103557	Thyroid Neoplas... Lymphatic Metas...	prophylactic se...	20 Years - 76 Years	Pusan National University Hospital

Spots Global Cancer Trial Database for lymphatic metastasis