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

NCT05568420 | Recruiting

• 1 other identifier: 22-254
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Pharmacologic; Colectomy specimens; 22-254

Outcome Measures

Primary Outcomes (1)

• genomic analysis of tissue

  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)

  3 years

Study Arms (2)

Colorectal Cancer Cohort

* Stool collection prior to starting treatment (i.e. chemotherapy, chemoradiotherapy, etc.) * Blood sample to be collected either prior to starting treatment (i.e. chemotherapy, chemoradiotherapy, etc.) or during surveillance. * Prospective tissue collection will be utilized from clinically indicated diagnostic colonoscopies/biopsies/resections s, including surveillance colonoscopies. Non-diagnostically indicated tissue collections will not be performed. Some EOCRC patients will have already undergone prior surgical resection, with tissue (including normal colonic mucosae distant from the malignant tumor). The pathology FFPE blocks may be used as a source of normal colon tissue for genomic analysis.

Healthy Control Cohort

Tissue collection of normal colon mucosa will be utilized from clinically indicated colonoscopies or from tissue obtained from a prior colonoscopy, non-diagnostically indicated tissue collections will not be performed. Colonoscopies for indications of IBD, anemia, and/or genetic predisposition will be excluded. * Stool samples will be collected at time of colonoscopy. Samples to be collected either within 3-14 days before or at least 14 days after colonoscopy, to avoid changes in microbiome caused by colonoscopy prep. * Blood samples will be collected at time of colonoscopy. * Risk factor questionnaire will be completed at time of colonoscopy. Will also try to collect stool from healthy control patients; however, if accrual is low after 3-6 months, remainder of cohort will be filled with specimen data from the Human Microbiome Project Data Portal.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified through the Center for Young Onset Colorectal and Gastrointestinal Cancer, a member of the patient's treatment team, the principal and coprincipal investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).

You may qualify if:

• CRC Cohort:
• 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:
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Shaare Zedek Medical Center: collaborator
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Stool, Blood and Tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Andrea Cercek, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Cercek, MD

CONTACT

646-888-4189; cerceka@mskcc.org

David Kelsen, MD

CONTACT

646-888-4179

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 5, 2022
• Study Start: September 30, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)