Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Genetic Predisposition to Disease

Disease Susceptibility

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Qing Lan, M.D.

Background:

* Women in Xuan Wei County, China, are almost all non-smokers, yet they have the highest lung cancer rate in that country.
* Non-smoking women in Xuan Wei who use smoky coal for cooking and heating homes can inhale 10 times higher levels of polycyclic aromatic hydrocarbons (PAH, compounds formed in many burning organic substances, including smoky coal) than someone who smokes 20 cigarettes a day.

Objectives:

* Determine the health effects of smoky coal in Xuan Wei and Fu Yuan counties in China's Yun Nan Province
* Determine how different levels of exposure to smoky coal and other types of fuel affect the amount of smoky coal emissions that are absorbed into the body
* Determine genetic risk factors for lung cancer in the study population and determine how they interact with smoky coal and PAH exposure.

Eligibility:

* Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who have lung cancer and do or do not use smoky coal
* Women from Xuan Wei and Fu Yuan counties between 18 and 79 years of age who do not have lung cancer and do or do not use smoky coal

Design:

-Exposure assessment study for users of smoky coal - 150 households

Use of air badges, monitors, and dermal badges to determine subjects' exposure to smoky coal

Collection of blood, urine, cheek cell and sputum samples to measure the amount of smoky coal emissions absorbed into the body and evaluate the types of biologic changes they cause

Interview subjects about their health and family history, occupational exposures, lifestyle factors (e.g., tobacco smoking and diet), and inherited differences in genes

-Case-control study - 1,000 women

Collection of blood, urine, cheek cell and sputum samples to measure how amount of smoky coal emissions absorbed into the body and evaluate types of biologic changes they cause

Interview subjects about their health and family history, occupational exposures, lifestyle factors (e.g., tobacco smoking and diet), and inherited differences in genes

Gene analysis to determine if a genetic variation is associated with an increased or decreased risk of health effects from smoky coal exposure

Females in Xuan Wei County are almost all non-smokers, yet they have the highest lung cancer rate in China. Non-smoking women in Xuan Wei who use smoky coal in their home can inhale ten times higher levels of PAHs than a 20 cigarette per day active smoker, and air concentrations approach levels experienced by workers on the top-side of coke ovens. Several lines of research have provided strong support that the excess lung cancer in this region is caused primarily by PAHs derived from smoky coal exposure. As such, this region of China provides one of the best opportunities in the world to carry out a model study of gene-environment interactions in lung cancer. We have designed a hospital-based case-control study of 500 lung cancer cases and 500 controls among non-smoking women, with controls to be selected through a randomized recruitment design to achieve balance for the main effects of smoky coal exposure and ultimately greater power to detect interactions. The study will be carried out over a three-year period in Xuan Wei and Fu Yuan Counties in Yun Nan Province, China. In addition, we will be carrying out an exposure assessment study (n=150 households) to evaluate air and dermal exposure to PAHs from smoky coal use in order to model PAH exposure experienced by subjects in the case-control study. We will collect buccal cell, sputum, blood, and urine samples from all subjects. The primary goal of the study is to characterize genetic risk factors at the DNA level for lung cancer in this population and determine how they interact with smoky coal and PAH exposure. In addition, the hospital-based design will enable us to collect venous blood samples and cryopreserve lymphocytes, which will allow us to carry out state-of-the-art functional susceptibility assays such as testing ability to repair PAH-damaged DNA and apoptotic capacity, and to measure integrative markers of genomic stability such as telomere length and oxidative damage in mitochondrial DNA. These types of assays have never been conducted in this population and hold great promise to provide insights into cancer risk that will compliment those obtained by genotyping. This study will provide an important complement to and contrast with both DCEG and extramural studies of tobacco smoking and lung cancer, where unraveling the genetic component is challenging in part because hundreds of tobacco carcinogens in various combinations likely contribute.

Smoky Coal Exposure, Genetic Susceptibility, and Lung Cancer in Non-Smoking Women in China

A Hospital-Based Case-Control Study of Non-Smoking Women in Xuan Wei and Fu Yua, China: PAH Exposure, Genetic Susceptibility, and Lung Cancer

Outcome from this study will include the observation of response-gradient for PAHs exposure due to indoor burning biomass and risk of lung cancer.

Outcome will involve discovering genes related to lung cancer risks among non-smoking Asian women.

Outcome will also involve the GXE analysis to explore the interaction between genetic factors and environmental exposure.

National Cancer Institute (NCI)

Herbal and Botanical

All Drugs and Chemicals

Sage

The proposed research intends to construct a set of tissue microarrays containing different types of normal and lung cancer tissues for the study of genes associated with lung cancer. Thus far we have generated a lung cancer tissue arrayusing paraffin embedded archival tissues from 300 lung turmors tissues and 100 adjacent normal tissues. Four- micrometer thickness sections have been cut from the tissue array and were used to survey gene expression status in arrayed tumors using immunohistochemistry methody. We are currently performing IHC studies ot 1) determine protein expression and its correlation with gene expression patterms ovserved using cDNA arrays. 2) Analyze protein expression in the chromosome remodeling pathyway in non-small cell lung cancer. And 3) determine the association of gene expression with lung tumor stage and clinical outcome. The current protocol is needed to complete the above studies and for the production of neuroendocrine tumors.

The proposed research intends to construct a set of tissue microarrays containing different types of lung cancer tissues for the study of genes associated with lung cancer. In this study, lung tissue arrays will be generated using paraffin embedded archival tissues containing adjacent normal tissues and tumors from approximately 300 non-small cell lung cancers and 100 neuroendocrine tumors of the lung. Corded tissues of 0.6 um in diameter will be taken from each tumor and arrayed onto recipient paraffin blocks to generate a lung tumor specific microarray. Four-micrometer thickness sections will be cut from the tissue array and used to survey gene expression status in arrayed tumors using fluorescence in situ hybridization (FISH, in situ hybridization, and/or immunohistochemistry methods. Additionally, approximately 20 sections will be cut from each primary tumor block to isolate genomic DNA for the analysis of genetic changes in the arrayed tumor samples. The goals of this proposal are 1) to generate a single tissue block containing multiple tumors, 2) allow rapid and efficient analysis of gene expressions in a large number of samples using a single tissue section, and 3) to correlate the molecular changes in the tumors with the clinical and pathological features of the disease. Due to the experimental nature of the research and the fact that all tumors obtained are archival tissues at AFIP, the investigators will not report the result of gene expression back to the subject.

To date, all samples needed for the protocol have been reached and there will be no more patient accrual but survival status of the patients as well as molecular analysis using the constructed lung tissue microarrays will continue for the foreseeable future.

Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

James Brooks, MD

The purpose of this study is to investigate gene expression profiles and biologic features of prostate tissue and how they relate to prostate cancer development and growth.

Microarray Analysis of Gene Expression in Prostate Tissues

Microarray Analysis of Gene Expression in Prostate Tissues (Translating Prostate Cancer Gene Expression Sub-types)

The Tissue Bank will store all "Tissue Bank" consents. The patients will be given a unique identifier by the tissue bank. However, patients will need to be identified to link to clinical data and possible followup (if they have consented) via chart or tumor registries.

National Institutes of Health (NIH)

University of Wisconsin, Madison

Stanford University

Neoplasm Metastasis

Neoplastic Processes

Benjamin Bretzinger

Felix Thomas

Dean Chou, MD

John O'Toole, MD

Daniel M Sciubba

Daniel M Sciubba, MD

John Shin

John Shin, MD

Michelle J Clarke, MD

Michelle Clarke, MD

Ilay Laufer, MD

Addisu Mesfin, MD

Meic Schmidt, MD

Rachel Lehrer, MD

James Schuster, MD

Ziya L Gokaslan, MD

Ziya Gokaslan, MD

Laurence D Rhines, MD

Tony Goldschlager, MD

Charles G. Fisher, MD

Michael Johnson, MD

Michael G Fehlings, MD

Arjun Saghal, MD

Michael Weber, MD

Alexander Disch, MD

Peter Varga

Peter Varga, MD

Alessandro Gasbarrini

Alessandro Gasbarrini, MD

Alessandro Luzzati, MD

Norio Kawahara, MD

Jorrit J Verlaan, MD

Naresh Kumar, MD

Cordula Netzer, MD

Netzer Cordula, MD

The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

To prospectively determine the prognostic variables (clinical, diagnostic, and therapeutic) within patients diagnosed with metastatic spine tumor(s) that are associated with:

* patient reported outcomes (HRQOL)
* morbidity data
* local tumor control
* survival

Outcome measures:

Variables which will be collected in the registry that are applicable to patients with metastatic spine tumor include:

* • Patient details
* Details of previous treatment
* Diagnosis
* Symptoms
* Treatment details for the index target
* Imaging information

The following outcome measures will be collected:

* Patient reported outcomes:

  * Euroqol EQ-5D-3L
  * Euroqol EQ-5D VAS - Quality of Life
  * Neck Pain Numeric Rating Scale (NRS)
  * Arm Pain NRS
  * Back Pain NRS
  * Leg Pain NRS
  * SOSGOQ
  * Patient assessment
* Ambulation
* Pain medication
* Nutritional Status Tool (PG-SGA©)
* Morbidity data
* Local disease recurrence data
* Overall survival data

Metastatic Tumor Research and Outcomes Network

Metastatic Tumor Research and Outcome Network A Multicenter Prospective Registry for the Management and Outcome of Metastatic Spine Tumors

The following patient data will be collected:

* gender, year of birth, height, weight, race
* work status, education level, marital status
* smoking, alcohol and recreational drug use
* medication use
* nutrition and vitamin intake
* presence of osteoporosis
* comorbidities according to the Charlson Comorbidity Index - CCI

Primary cancer

* Site of the primary cancer
* Year of diagnosis
* Status of the tumor (removed completely, partially, or not removed)
* Signs of local control or tumor progression
* Tumor subtype
* Tumor markers

Spine metastases

* Date of initial diagnosis of spine metastases
* Identification of index target
* Vertebral location (i.e., C1, T3-T5, etc.)
* Details of spine metastases and other metastases, if any
* Activity of systemic metastases
* Local control of metastatic tumor
* Presence of pathologic fracture
* Radiographic evidence of new spine metastatic disease

For patients with metastatic spine tumor, it is important to understand the occurrence, location, and type of pain patients have at baseline and at follow-up visits. Pain symptoms assessed by the physician will therefore be collected in addition to the pain specific PROs.

Bowel and bladder function will be assessed by the physician.

If the patient had previous treatment (surgery, radiation or systemic oncologic therapy) for the index target, the following information about the previous treatment will be collected at baseline:

* Type(s) of treatment
* Date(s) of treatment
* Treated vertebrae level(s)
* Procedure details
* Hospital/center where the treatment was administered
* ASIA impairment scale (applies only to previous surgical patients)

Skeletal muscle and adipose tissue measurements will be made from CT scans. One transverse CT image of the inferior surface of L3 will be assessed by an independent assessor to calculate the visceral fat area to subcutaneous fat ratio (VFA/SFA ratio). This measurement will only be collected if the CT scan is according to standard of care and the method is described in a separate imaging manual. Additional CT scans will not be performed for this Registry.

Imaging is critical to select the biopsy technique and for disease diagnosis. Follow-up imaging also plays an important role in monitoring disease status. Imaging data will be collected to serve as a data repository, so that images may be more easily retrieved later if necessary.

Imaging data

* Image type (e.g. MRI, CT, PET, etc.)
* Date taken
* Name of institution storing image

The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

Details about the ability of the patient to walk, cause of ambulation loss, use of an assistive device, and timing will be collected.

10 meter walk test (10 MWT) If the patient is able to ambulate without physical assistance (i.e. without help of a person), ambulation will be assessed by the 10MWT (walking aids are allowed). The 10MWT evaluates the time required to walk 10 meters. Patients should walk 10 meters with 2 meters for acceleration and deceleration. The patient will be timed from when the patient's toes of the leading foot cross the 2 meter line to when the patient's toes of the leading foot cross the 8 meter line. The test should be performed three times and the results will be averaged. The patient should be instructed to perform the test at a comfortable walking pace.

The Scored Patient-Generated Subjective Global Assessment (PG-SGA©) sets the standard of and is the preeminent interdisciplinary patient assessment (weight, intake, symptoms, functional status, disease state, metabolic stress and nutritional physical examination) in oncology and other chronic catabolic conditions.

The Scored PG-SGA© includes the four patient-generated historical components ('Weight History', 'Food Intake', 'Symptoms' and 'Activities and Function'), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage recommendations. Subsequently, the Scored PG-SGA© allows for triaging of specific nutrition interventions, as well as facilitating quantitative outcomes data collection.

This assessment is available in a variety of languages and as a metric as well as a non-metric version.

* related to surgery Intra- and postoperative complication data will be recorded for all surgically treated patients during the standard of care scheduled follow-up visits. Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up. The Spine AdVerse Events Severity system, version 2 (SAVES V2) AE abstraction tool will be used to record the morbidity data.
* related to radiation and/or systemic oncologic therapy

For patients treated with RT and/or systemic oncologic therapy, complications and severity grade related to the treatment will be recorded during the standard of care scheduled follow-up visits according to a predefined list:

The predefined list and severity grading system are according to the National Cancer Institute Guidelines.

At every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease control. Presence or absence of local control and distant metastases should be confirmed through imaging. The timing of the assessment will be performed in accordance with local standard of care scheduled FU visits.

FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive.

Since there is a spectrum of different treatment options and combinations for patients with a metastatic spine tumor, detailed information about the three main treatment options (surgery, radiation, and systemic oncologic therapy) for the index target will be collected. The treatment intent, including administration (primary, neo-adjuvant, and adjuvant) will also be collected.

Information on the status of the primary cancer as well as on ongoing treatment of the primary cancer will be collected at baseline and at follow-up.

The Pain NRS is an 11-point scale where the end points are the extremes of no pain (0 points), or worst imaginable pain (10 points). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.

This is a new HRQOL outcome tool which was developed specifically for metastatic spine tumor. It is currently available in English and Hungarian. It contains 20 items representing all four domains of the International Classification of Function and Disability. Additionally there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health and social function. It was developed as a comparison to the SF-36 for patients with spine tumors.

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) ISNCSCI is a standardized examination to determine neurologic function and has been a standard clinical assessment for patients with neurological deficit. The modified ISNCSCI used in this study will assess the Motor Score and the American Spinal Injury Association (ASIA) Impairment Scale

The ECOG developed a scale from 0 to 5 to assess the patient's disease progression and how the disease affects the patient's daily living abilities (9). The lower the score the better the status of the patient, being 0 fully active and 5 dead.

The Spine Oncology Study Group developed and validated a 6-point grading system to describe the degree of epidural spinal cord compression based on axial T2-weighted MR images at the site of most severe compression. This assessment can be used to help guide treatment and can serve as a classification scheme.

The SOSG developed and validated a classification system to assist clinicians in defining tumor-related instability. It is assessed by adding together six individual component scores: spine location, pain, lesion bone quality, radiographic alignment, vertebral body collapse, and posterolateral involvement of the spinal elements. SINS has demonstrated clinically acceptable reliability among surgeons, radiation oncologists, and radiologists. The total SINS score can range from a score of 0 to 18. The total score has been divided into three categories of stability: stability (score of 0-6), indeterminate instability (score of 7-12), and instability (score of 13-18). Surgical consultation is recommended for patients with SINS scores ≥ 7. SINS will be assessed at baseline and/or prior to first prospective treatment. The most severe lesion within the index target should be assessed.

AO Foundation, AO Spine

AO Innovation Translation Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Fluorodeoxyglucose F18

Imaging studies and serum markers (CEA, CA 15.3, others) performed according to local practice

Serum CEA and CA 15.3 performed every 3 months. No imaging studies allowed in asymptomatic patients: imaging studies (18 FDG-PET) performed only in case of critical increase of CEA and /or CA 15.3 serum levels (+100% for CEA and +75% for CA15.3), even if in the normal range.

Tumor markers assessment every three months through the study or until disease recurrence

Arm B, tumor markers assessment

Claudio Zamagni, MD

The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.

Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

Three-monthly Dynamic Evaluation of CEA and CA 15.3 vs Usual Practice in the Follow-up of Early Breast Cancer Patients: a Randomized Study

Primary objective of the study is to verify if the experimental arm (serial measurement of serum CEA and CA 15.3 with diagnostic imaging procedures - i.e. 18FDG-PET- performed only in case of critical increase of serum markers level) can anticipate the diagnosis of breast cancer loco-regional (except for in-breast recurrence) or distant metastases compared to the control arm (usual follow-up practice).

Secondary objective is to evaluate the Positive Predictive Value (PPV) and the Negative Predictive Value (NPV) of CEA and CA15.3 dynamic changes in the diagnosis of breast cancer loco-regional (except for in-breast recurrence) or distant metastases.

Secondary objective is to perform an exploratory analysis on diagnostic anticipation in the different subtypes (ER and HER2 status)

Secondary objective is to measure how many imaging diagnostic tests will be avoided in the experimental arm compared to the control arm

Secondary objective is to compare the quality of life in the two arms

PONS-S (Patientenorientierte Nachsorge-Stiftung), Augsburg, Germany

Azienda ULSS 12 Veneziana

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

IRCCS Azienda Ospedaliero-Universitaria di Bologna

MD Medical Oncologist

Chetan Bettegowda, MD

John H Shin, MD

Mark Bilsky

Ori Barilai, MD

Ziya L. Gokaslan, MD

Laurence D. Rhines, MD

Nicolas Dea, MD

Yoga Raja Rampersaud, MD, PhD

Feng Wei, MD

Alexander Disch, PD, MD

Aron P Lazary, MD

Jeremy Reynolds

Jeremy Reynolds, MD

This project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. Demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (AEs), morbidity data, and health-related quality of life (HRQOL) outcomes.

Objective: To prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with:

* survival
* local recurrence
* morbidity data
* patient reported outcomes

Outcome measures: Variables applicable to primary spinal column tumor patients which will be collected in the registry include:

* Patient details
* Treatment status
* Details of previous treatment
* Diagnosis and biopsy types
* Tumor details
* Oncological staging
* Symptoms
* Treatment details
* Imaging information

We aim to collect the following outcome measures:

* Overall survival data
* Local disease recurrence data
* Morbidity data
* Patient reported outcomes:
* Euroquol-5D-3L, EQ-5D-Y (if applicable)
* Euroquol EQ-5D VAS - Quality of Life
* Neck pain numeric rating scale (NRS)
* Arm pain NRS
* Back pain NRS
* Leg Pain NRS
* SF-36 version 2
* SOSG Outcome Questionnaire (SOSGOQ) v1.0 and v2.0
* Surverys on patient expectations and satisfaction

Tumor tissue and adjacent normal tissue Blood

Primary Tumor Research and Outcomes Network

Primary Tumor Research and Outcomes Network (PTRON) A Multicenter Prospective Registry for the Management and Outcomes of Primary Tumors of the Spine

FU visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit it will be assessed if the patient is still alive

At first prospective treatment and every FU visit, each patient, regardless of which stage they are at in their treatment, will be evaluated for local disease recurrence. Patients that are classified as "non-virgin" will be evaluated for local disease recurrence also at baseline.

Complications will be assessed by evaluating the patient's medical files from the time treatment was initiated until the day of follow-up.

Intraoperative complications: (Airway/ventilation; Allergic reaction; Anesthesia related; Bone implant interface failure requiring revision; Cardiac; Cord injury; Dural tear; Hardware malposition requiring revision; Hypotension ; Massive blood loss ; Nerve root injury; Pressure sores; Vascular injury; Visceral injury; Other).

Pre-/post treatment complications: (Cardiac arrest/failure/arrhythmia; Construct failure with loss of correction; Construct failure without loss of correction; CSF leak/meningocele; Deep vein thrombosis; Deep wound infection; Delirium; Dysphagia; Dysphonia; GI bleeding; Hematoma; Myocardial infarction; Neurologic deterioration; Non-union; Pneumonia; Postoperative neuropathic pain; Pressure sores; Pulmonary embolism; Superficial wound infection; Systemic infection; Urinary tract infection; Wound dehiscence; Other)

The EuroQOL group developed a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it contains 5 questions and provides a simple descriptive profile and a single index value for health status.

EQ-5D is designed for self-completion by respondents and is ideally suited for use in mailed surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.

It will be assessed for neck, back, leg and arm. The Pain NRS is an 11-point horizontal scale where the end points are the extremes of no pain (0) and pain as bad as it could be, or worst pain (10). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.

It is a multipurpose, short-form health survey with 36 questions. It yields an eight-scale profile of scores: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. In addition, two composite scores are constructed using factorial modeling, one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS). A scoring algorithm is available using linear T-score transformation that translates scores using population based norms into scores with mean = 50 and standard deviation = 10. The algorithm is available for all 8 subscales as well for the PCS and MCS.

This is a new HRQOL outcome tool which was developed specifically for metastatic spine disease. It is currently available in English and Hungarian. It contains 20 items representing all four domains of the International Classification of Function and Disability. Additionally, there are seven follow-up questions referring to treatment satisfaction. It is made up of five domains: physical function, neural function, pain, mental health, and social function. During the first phase of this registry, patients completed the SOSGOQ version 1.0. The English SOSGOQ version 2.0 was released in January 2018 and will be used

A survey on the patient's expectation regarding the surgery. Only applicable for patients that receive surgical treatment.

A survey on the patient's satisfaction post-surgery. Only applicable for patients that receive surgical treatment.

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.

Tumor markers

Massimo Raimondo, M.D.

Purpose of this study is to understand the clinical feasibility of duodenal juice diagnosis to screen UICC stage II pancreatic ductal adenocarcinoma patients.

Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient.

The investigators would like to standardize the detection method of pancreatic cancer that uses the duodenal juice as an optional endoscopic diagnosis. It's a very useful chance to collect pancreatic juice from duodenum, it is called "duodenal juice" ,if we collect them without additional invasion. The investigators would like to collect duodenal juice during undergoing upper gastrointestinal endoscopy and analyze the pancreatic tumor markers in duodenal juice. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis and the result of each definite diagnosis is correlated to the each marker analyzing result of duodenal juice. Therefore this study can be positioned as a feasibility study to confirm clinical performance.

Pancreatic Juice Diagnosis From Duodenum

We hypothesized that there is a statistically-significant difference between two cohorts.

The cancer marker is S100P.

Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.\<Method\>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)

Mayo Clinic

Kyushu University

The University of Texas Health Science Center, Houston

Olympus Corporation

UICC StageII pancreatic ductal adenocarcinoma cohort

Test Subject

Normal

UICC Stage II pancreatic ductal adenocarcinoma cohort

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Smoky Coal Exposure, Genetic Susceptibility, and Lung Cancer in Non-Smoking Women in China	NCT00482118	Lung Neoplasms		18 Years - 79 Years	National Institutes of Health Clinical Center (CC)
Construction and Use of Lung Tumor Microarray for the Analysis of Gene Expression in Lung Cancer	NCT00340847	Lung Cancer		-	National Institutes of Health Clinical Center (CC)
Microarray Analysis of Gene Expression in Prostate Tissues	NCT00186368	Prostate Cancer		18 Years -	Stanford University
Microarray Analysis of Gene Expression in Prostate Tissues	NCT00186368	Prostate Cancer		18 Years -	Stanford University
Metastatic Tumor Research and Outcomes Network	NCT02830451	Metastatic Spin...		18 Years -	AO Innovation Translation Center
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET	NCT02261389	Breast Cancer	Arm B, tumor ma...	18 Years - 75 Years	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET	NCT02261389	Breast Cancer	Arm B, tumor ma...	18 Years - 75 Years	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Microarray Analysis of Gene Expression in Prostate Tissues	NCT00186368	Prostate Cancer		18 Years -	Stanford University
Primary Tumor Research and Outcomes Network	NCT02790983	Spinal Column T...		-	AO Innovation Translation Center
Pancreatic Juice Diagnosis From Duodenum	NCT01699698	Pancreatic Aden...	Tumor markers	18 Years -	Olympus Corporation

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