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Trial Title:
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
NCT ID:
NCT05568420
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Pharmacologic
Colectomy specimens
22-254
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Potential research subjects will be identified through the Center for Young Onset
Colorectal and Gastrointestinal Cancer, a member of the patient's treatment team, the
principal and coprincipal investigator, or research team at Memorial Sloan Kettering
Cancer Center (MSKCC).
Sampling method:
Non-Probability Sample
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
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
49 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea Cercek, MD
Phone:
646-888-4189
Contact backup:
Last name:
David Kelsen, MD
Phone:
646-888-4179
Start date:
September 30, 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05568420
http://www.mskcc.org/mskcc/html/44.cfm
