Understanding young onset colorectal cancer through biospecimen collection
Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer
This study is collecting blood, tissue, and stool samples from people aged 18-49, both with and without young onset colorectal cancer, to better understand what might cause this type of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05568420 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect biospecimens, including blood, tissue, and stool samples, along with health information, to create a comprehensive database for better understanding young onset colorectal cancer (YOCRC). It will involve participants aged 18-49 years, both those diagnosed with YOCRC and healthy individuals undergoing standard colonoscopy. The study seeks to analyze the differences in biological markers and health data between these two groups to identify potential factors influencing YOCRC.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-49 with a diagnosis of colorectal adenocarcinoma or healthy individuals scheduled for a standard colonoscopy.
Not a fit: Patients with known inherited cancer susceptibility genes or a history of inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of young onset colorectal cancer, potentially informing future treatment strategies.
How similar studies have performed: While there have been studies on colorectal cancer, this specific focus on young onset colorectal cancer and the collection of diverse biospecimens is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Cercek, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Andrea Cercek, MD
- Email: cerceka@mskcc.org
- Phone: 646-888-4189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.