Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT05568420
Eligibility Criteria:
Inclusion Criteria:
CRC Cohort:
* 18-49 years old
* Histological or cytological diagnosis of colorectal adenocarcinoma
* Planned CRC resection biopsy, or colonoscopy ,including surveillance colonoscopies and/or have already undergone prior surgical resection, with tissue, including normal colonic mucosae distant from the malignant tumor (only patients providing tissue sample)
* Enrollment in IRB# 20-315, Young Onset Gastrointestinal Cancer Prospective Registry (Andrea Cercek, PI)
Healthy Control Cohort:
* 18-49 years old at time of diagnosis
* Scheduled for standard-of-care colonoscopy at MSK
* Underwent surgical resection of a traumatic injury to the colon at Shaare Zedek Medical Center (SZMC)
Exclusion Criteria:
* CRC Cohort:
* Antibiotic use within 6 months of collection of stool for gut microbiome analysis s (only patients providing stool sample)
* Known inherited cancer susceptibility gene
* History of inflammatory bowel disease
Healthy Control Cohort:
* Antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample)
* History of or prior treatment for cancer ≤ 5 years prior to registration. Exceptions include non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.
* Colonoscopy for indications of IBD, anemia and/or genetic predisposition (only patients providing tissue sample).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05568420
Study Brief:
Protocol Section:
NCT05568420