A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer
Overview
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]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT05568420 · 22-254