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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05568420
Recruitment Status : Recruiting
First Posted : October 5, 2022
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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.

Condition or disease
Colorectal Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer
Actual Study Start Date : September 30, 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. genomic analysis of tissue [ Time Frame: 3 years ]
    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)


Biospecimen Retention:   Samples With DNA
Stool, Blood and Tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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).
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
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568420


Contacts
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Contact: Andrea Cercek, MD 646-888-4189 cerceka@mskcc.org
Contact: David Kelsen, MD 646-888-4179

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrea Cercek, MD    646-888-4189      
Contact: David Kelsen, MD    646-888-4179      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Andrea Cercek, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05568420    
Other Study ID Numbers: 22-254
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Pharmacologic
Colectomy specimens
22-254
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases