A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05568420
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

This study will collect biospecimens (including blood, tissue, and stool samples) and health information to create a database-a type of collection of information-for better understanding young onset colorectal cancer (YOCRC). The study will include both people with YOCRC and healthy people.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
genomic analysis of tissue	3 years	For the genomic analyses, we will perform whole exome sequencing, MSK-IMPACT DNA-methylation and RNA assays of normal colonic mucosa and tumor. Other genomic analysis may be performed depending on the results of the initial analysis developments in this field. We will compare normal mucosa plus tumor in YOCRC vs normal mucosa in controls (using biopsies collected during outpatient colonoscopies not associated with hospitalizations)

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States