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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal Cancer Cohort<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genomic analysis of tissue | 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) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacologic, Colectomy specimens, 22-254