NCT05568420 · Memorial Sloan Kettering Cancer Center
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Collaborators
Shaare Zedek Medical Center, Technion, Israel Institute of Technology
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations