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NCT Number: NCT05568420

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

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.

Recruiting

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Andrea Cercek, MD

CONTACT

646-888-4189

David Kelsen, MD

CONTACT

646-888-4179

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Cercek, MD

CONTACT

[email protected]

646-888-4189

David Kelsen, MD

CONTACT

646-888-4179

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Shaare Zedek Medical Center
  • Technion, Israel Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2022
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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