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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568420
• Other study ID #: 22-254
• Status: Recruiting
• Start date: September 30, 2022
• Est. completion date: September 2025

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Andrea Cercek, MD
• Phone: 646-888-4189
• Email: cerceka[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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
• Scheduled for standard-of-care colonoscopy at MSK

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).

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center