Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: t
View:

⁃ 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)

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Andrea Cercek, MD
cerceka@mskcc.org
646-888-4189
Backup
David Kelsen, MD
646-888-4179
Time Frame
Start Date: 2022-09-30
Estimated Completion Date: 2026-09
Participants
Target number of participants: 160
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: Technion, Israel Institute of Technology, Shaare Zedek Medical Center

This content was sourced from clinicaltrials.gov