Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer

Memorial Sloan Kettering Cancer Center1 site in 1 country160 target enrollmentSeptember 30, 2022

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 160
Locations: 1
Primary Endpoint: genomic analysis of tissue
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 30, 2022

End Date

September 1, 2026

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

genomic analysis of tissue

Time Frame: 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)