Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Adenoma

Colonic Polyps

Polyps

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Colonic Diseases

Blood and stool specimen collection.

Study samples must be collected prior to any treatment.

Blood and stool specimen collection.

Samples must be collected prior to performing bowel preparation for the colonoscopy.

Girish Putcha, M.D., Ph.D

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.

Early detection of cancer combined with effective treatment improves survival and quality of life. Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay for the early detection of colorectal cancer. The study will collect blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous lesions could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and early detection.

Freenome is looking for three types of patients in this study:

Cohort A:

People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.

Cohort B:

People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy.

Cohort C:

People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.

AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test

Specimen Collection Study for Cancer

Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.

Freenome Holdings Inc.

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Ovarian Neoplasms

Leukemia

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Sarcopenia

Neoplasms, Second Primary

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Breast Neoplasms

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lung Neoplasms

Lymphoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Kidney Neoplasms

Hematologic Diseases

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Neoplastic Processes

Bone Marrow Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Breast Diseases

Skin Diseases

Myeloproliferative Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urogenital Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Quality of Life

Ovarian Cancer

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Myeloproliferative Disorders

Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire

Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Standard

Magali BALAVOINE

Katell LE DU, MD

Julien DOMONT, MD

Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.

Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.

Sarcopenia is defined for those under 60 years of age by LMSI\<43.1 cm²/m² for men and \<32.7 cm²/m² for women, and for patients over 60 years of age by \<38.6 cm²/m² for men and \<30.7 cm²/m² for women..

Calculated from the date of inclusion to the date of death due to any cause or the date last known to be alive if patient is censored.

Calculated from the date of start of treatment to the date of first event (progression, death, infectious complications, thrombosis, side effects of treatments of grade 2 or higher)

Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression

Calculated from the date of start of treatment for all unplanned hospitalizations for side effects of treatments of grade 2 or higher, infectious complications, thrombosis, relapse or progression

For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)

Calculated according to WHO classification

Calculated from the number of patients who were screened for sarcopenia at diagnosis in the active file of patients meeting the inclusion criteria in all participating centers

Weprom

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

The intervention of TNT group is Short-course radiotherapy with neoadjuvant chemotherapy, which consists of a short-course radiotherapy (SCRT, 5 Gy x 5 alone), then after 7-10 days of radiotherapy completed, patients will receive neoadjuvant chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy. If patients are eligible for postoperative chemotherapy this should consist of at least 2 cycles, which are the same as neoadjuvant chemotherapy.

The intervention of CRT group is long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively, followed by a total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends. If patients are eligible for postoperative chemotherapy this should consist of at least 6 cycles of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once every 3 weeks.

Short-course radiotherapy with 4 cycles of neoadjuvant chemotherapy

Short-course radiotherapy with neoadjuvant chemotherapy

Long-term chemoradiotherapy

Yuan Tang

Jing Jin

Yang Tang

The purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.

The study is a prospective phase III randomized multicenter trial. The purpose of this study is to compare short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) for middle-lower locally advanced rectal cancer. The primary endpoint is 3-year disease-free survival,defined as the interval from randomization to the first occurrence of local-regional failure, distant metastasis, second primary tumor or death from any cause. The primary hypothesis was that DFS in the TNT group would be non-inferior to that in the CRT group. After preoperative radiotherapy and surgery, the DFS rate of LARC fluctuated from 50% to 65%. Assuming a 3-year DFS rate in CRT group is 65%, we consider the 3-year DFS rate in the TNT group is not lower than 54% (e.g., a margin of 11% or equivalently, hazard ratio (HR) \< 1.43). Guarding against a 5% ineligibility or drop-out rate, the accrual target was 600 patients, with the final analysis to occur after at least 194 DFS events to provide at least 80% power at 1-sided type 1 error of 0.05. The choices of type 1 error and power were made to provide an appropriate comprise between feasibility, timeliness and statistical rigor of evidence generation.

This study seeks to compare outcomes between two groups with respect to rates of overall survival(OS), distance metastasis free survival (DMFS), and locoregional recurrence free survival (LRRFS).In addition, acute and late toxicity profile, completion of preoperative treatment, the proportion of patients with radical resection (R0), surgical complication profile, the rate of pathological complete response (pCR), and quality of life (QoL) are also secondary endpoints.

The STELLAR-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.

Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer

Phase III Study of Short-term Radiotherapy Plus Neoadjuvant Chemotherapy Versus Preoperative Long-term Chemoradiotherapy in Locally Advanced Rectal Cancer

Surgical complications are defined as those occurring within 30 days after surgery, such as re-operation, anastomotic fistula, bleeding, infection and death related to the operation, etc.

Number of participants with abnormal laboratory values and/or adverse events that are related to radiation or chemotherapy as assessed by Common Toxicity Criteria for Adverse Effects(CTCAE) v4.0.

R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy

PCR rate is pathological ypT0N0 probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy

Quality of life will be assessed using the EORTC QLQ C30, EORTC QLQ Cr29 and Wexner score.

Chinese Academy of Medical Sciences

vice director of Radiotherapy Department

Ahmed Abdel-wanis, Resident

Mohamed Elbaroudy, Lecturer

Ahmed Abd El-wanis, Resident

Ahmed Abd Elwanis, Resident

Shymaa Abdallah, Lecturer

Hossam Eldin Galal, Proffesor

The purpose of our study is to evaluate the accuracy of MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer .

The current standard of care for patients with T3 or T4 and/or node-positive rectal adenocarcinoma is to offer preoperative concomitant chemoradiotherapy(CRT) followed by total mesorectal excision (TME). 1 In 10-24% of patients, no residual tumor is found at histology after surgery.2 These complete responders are known to have a very good prognosis, in terms of overall and disease-free survival.2 A complete response also raises the hotly debated question of whether surgery is still necessary for these patients, especially because total mesorectal excision (TME) may have associated morbidity and even mortality and has the potential risk of a permanent colostomy.

Recently, a more conservative treatment is advocated in patients who show a good or complete response to neoadjuvant treatment. In 2006, Habr-Gama et al. Presented the long-term results of a prospective trial that investigated a "wait-and-see" policy in a carefully selected group of patients with clinical and radiological evidence of a complete response after neoadjuvant CRT. Results at 5-year follow-up were favorable for the nonsurgical group, with an overall and disease-free survival of 93% and 85%, respectively 3.

Recently, A watch and wait policy avoids the morbidity associated with radical surgery and preserves oncologic outcomes. It could be considered a therapeutic option in patients with locally advanced rectal cancer following chemoradiotherapy with a complete clinical response.4 To safely omit surgery, it is essential to select accurately the right candidates, i.e., the true complete responders. This selection is mainly performed using digital examination, endoscopy, and biopsy, but these methods are not infallible.

High-resolution magnetic resonance imaging (MRI) has been used to assess tumor response before surgical resection. By applying the principals of histopathologic TRG and by exploiting the characteristic MRI low-signal-intensity appearances of fibrosis, it has been possible to develop a similar MRI-based TRG system. The MRI-assessed TRG (mrTRG) was found to be an independent prognostic factor for overall survival (OS) and DFS.5 Complete pathologic response (pCR) after CRT has led to the proposal of a nonoperative approach as an alternate treatment for highly selected patients with a complete clinical response (CR). Habr-Gama et al reported findings from 99 patients with a clinical CR who were treated with observation alone. The 5-year OS and DFS rates were 93% and 85%, respectively.6 In a recent study, MRI-assessed complete tumor response was strongly correlated with pathologic complete response and, therefore, can be used as a surrogate marker to predict absence of viable tumor cells.7 Recently, Diffusion-weighted MRI (DWI) could be useful for response evaluation after chemoradiation treatment (8-10) In 2009, Kim et al. showed in a study of 40 patients that DWI in addition to standard MRI significantly improved the performance of radiologists to select complete responders compared with standard MRI only

MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer

MRI for Response Evaluation After Chemoradiation for Locally Advanced Rectal Cancer

The purpose of our study is to evaluate the accuracy of MRI for response evaluation

after chemoradiation for locally advanced rectal cancer . Primary outcome includes Tumor site, size, volume, extension, T2, DWI signal intensity.

Secondary outcome after chemo-radiotherapy in T2, DWI signal intensity changes

in T2, DWI signal intensity changes T2, DWI signal intensity changes

Assiut University

Resident

Surgical resection for cancer rectum

Abdallah M Taha, MD

This study was conducted to compare the significance of lymph node ratio and absolute count of positive lymph node count on overall survival in patients with rectal cancer who underwent resection with curative intent

Retrospective cohort study carried on 229 patients with non-metastatic rectal cancer, admitted in tertiary hospitals along 10 years, between 2012 to 2022, and underwent radical resection surgery with curative intent.

Exclusion criteria included patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, early post-operative recurrence or death within 3 months. Demographic, histopathological, follow up and outcome data were collected.

Demographics included age, gender, family history, and chief complaint at presentation. Histopathological data included tumor site, grade, vascular-perineural invasion, total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio was defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in histopathology specimen. Survival was calculated for each patient based on time of surgery to time of death

Statistical analysis will be used to evaluate the effect of lymph node ratio on overall survival.

Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival

Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival: An Alternative Not a Substitute

Survival was calculated for each patient based on time of surgery to time of death.

South Valley University

Associate professor of General Surgry

Sigmoid Neoplasms

Colonic Neoplasms

Sigmoid Diseases

Herbal and Botanical

Cola

proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.

embolization of the inferior mesenteric artery

Endovascular ligation of Inferior mesenteric artery

Inferior mesenteric artery ligation

Martin Bertrand, MD

The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.

Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery

Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery - A Single-center Feasibility Pilot Study.

Rectal resistance index measured by Doppler

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test	NCT03688906	Colo-rectal Can... Cancer Colon Cancer, Rectum Neoplasms,Color... Polyps Polyp of Colon Adenoma Adenoma Colon		18 Years -	Freenome Holdings Inc.
Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy	NCT05154474	Metastatic Canc... Cancer, Breast Cancer Colon Cancer, Rectum Cancer, Lung Cancer Ovaries Cancer Prostate Cancer, Kidney Cancer Pancreas Myeloma Myelodysplasia Leukemia, Myelo... Leukemia,Myeloi... Leukemia, Lymph... Leukemia, Lymph...	Standard	18 Years -	Weprom
Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer	NCT02533271	Cancer, Rectum	Short-course ra... Long-term chemo...	18 Years - 70 Years	ChineseAMS
MRI for Selection of Complete Responders After Chemoradiation for Locally Advanced Rectal Cancer	NCT04790227	Cancer, Rectum	MRI	18 Years - 90 Years	Assiut University
Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival	NCT05667259	Cancer, Rectum	Surgical resect...	19 Years - 90 Years	South Valley University
Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery	NCT03628248	Cancer, Sigmoid Cancer, Rectum	embolization of... Inferior mesent...	18 Years - 80 Years	Centre Hospitalier Universitaire de Nīmes
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test	NCT03688906	Colo-rectal Can... Cancer Colon Cancer, Rectum Neoplasms,Color... Polyps Polyp of Colon Adenoma Adenoma Colon		18 Years -	Freenome Holdings Inc.

Spots Global Cancer Trial Database for cancer, rectum