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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05568420
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: Colorectal Cancer Cohort
    * Stool collection prior to starting treatment (i.e. chemotherapy, chemoradiotherapy, etc.) * Blood sample to be collected either prior to starting treatment (i.e. chemotherapy, chemoradiotherapy, etc.) or during surveillance. * Prospective tissue collection will be utilized from clinically indicated diagnostic colonoscopies/biopsies/resections s, including surveillance colonoscopies. Non-diagnostically indicated tissue collections will not be performed. Some EOCRC patients will have already undergone prior surgical resection, with tissue (including normal colonic mucosae distant from the malignant tumor). The pathology FFPE blocks may be used as a source of normal colon tissue for genomic analysis.
  • Arm: Healthy Control Cohort
    Tissue collection of normal colon mucosa will be utilized from clinically indicated colonoscopies or from tissue obtained from a prior colonoscopy, non-diagnostically indicated tissue collections will not be performed. Colonoscopies for indications of IBD, anemia, and/or genetic predisposition will be excluded. * Stool samples will be collected at time of colonoscopy. Samples to be collected either within 3-14 days before or at least 14 days after colonoscopy, to avoid changes in microbiome caused by colonoscopy prep. * Blood samples will be collected at time of colonoscopy. * Risk factor questionnaire will be completed at time of colonoscopy. Will also try to collect stool from healthy control patients; however, if accrual is low after 3-6 months, remainder of cohort will be filled with specimen data from the Human Microbiome Project Data Portal.

Primary Outcome Measure

genomic analysis of tissue [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Andrea Cercek, MD
646-888-4189
David Kelsen, MD
646-888-4179

Find similar trials in New York, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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