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Collection of Information to Better Understand Young Onset Colorectal Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04489238
Collaborator
(none)
666
Enrollment
8
Locations
36
Anticipated Duration (Months)
83.3
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this registry study is to create a database-a collection of information-for better understanding young onset colorectal cancer. Colorectal cancer patients are considered to have young onset colorectal cancer if they are diagnosed with their cancer before the age of 50. Researchers will use the information from this database to learn more about how young onset colorectal cancer may be similar to or different from colorectal cancer that is diagnosed later in life. Researchers will also use information from the database for current and future research on young onset colorectal cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Risk Factor Questionnaire

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
666 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Young Onset Gastrointestinal Cancer Prospective Registry
Actual Study Start Date :
Jul 22, 2020
Anticipated Primary Completion Date :
Jul 22, 2023
Anticipated Study Completion Date :
Jul 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Young onset Colorectal Cancer Participants

(Stool collection on newly diagnosed patients in this cohort) Participants will include patients under the age of 50 who are diagnosed with colorectal adenocarcinoma.

Other: Risk Factor Questionnaire
Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
Other Names:
  • CYOC Risk Factor Questionnaire

    		•
    Average onset Colorectal Cancer Participants

    (Stool collection cohort only) 166 colorectal cancer patients 50 year-old or older will serve as controls. Stool collection cohort only.

    Other: Risk Factor Questionnaire
    Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
    Other Names:
  • CYOC Risk Factor Questionnaire

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Establish a prospective database of patients with Young Onset Colorectal Cancer [1 year]

      from diagnosis through survivorship

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Participant Inclusion Criteria for database and questionnaire (YOGI)

    • Histological or cytological diagnosis of gastrointestinal cancer

    • 18 - 49 years old at time of consent

    • No Known hereditary CRC or other cancer predisposition syndrome (stool collection cohort only)

    • No history of inflammatory bowel disease (stool collection cohort only)

    • No prior diagnosis of gastrointestinal cancer (stool collection cohort only)

    Participant Inclusion Criteria for database and questionnaire (Controls)

    • Histological or cytological diagnosis of colorectal adenocarcinoma

    • No previous treatment for CRC (including surgery, chemotherapy, immunotherapy or radiation)

    • Age 50 or older at time of consent

    • No Known hereditary CRC or other cancer predisposition syndrome

    • No history of inflammatory bowel disease

    • No prior diagnosis of CRC

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Basking Ridge New Jersey United States 07920
    2 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Cancer Center @ Commack Commack New York United States 11725
    5 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    6 MSK at Ralph Lauren New York New York United States 10035
    7 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    8 Memorial Sloan Kettering Nassau Rockville Centre New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Andrea Cercek, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04489238
    Other Study ID Numbers:
    • 20-315
    First Posted:
    Jul 28, 2020
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    young onset colorectal cancer
    colorectal registry
    20-315
    Memorial Sloan Kettering Cancer Center
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Oct 11, 2021