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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05568420

Enrollment

Registered

2022-10-05

Start date

2022-09-30

Completion date

2027-09-01

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Pharmacologic, Colectomy specimens, 22-254

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrea Cercek, MD

Memorial Sloan Kettering Cancer Center

Outcome results