Collection of Information to Better Understand Young Onset Colorectal Cancer

Young Onset Gastrointestinal Cancer Prospective Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Carcinoma
• Intervention / Treatment: Other: Risk Factor Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 1366

Contacts and Locations

• Study Contact: Name: Rona Yaeger, MD; Phone Number: 646-888-5109; Email: yaegerr@mskcc.org
• Study Contact Backup: Name: Andrea Cercek, MD; Phone Number: 646-888-4189; Email: cerceka@mskcc.org

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: Andrea Cercek, MD; Phone Number: 646-888-4189
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth
      • Contact: Andrea Cercek, MD; Phone Number: 646-888-4189
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen
      • Contact: Andrea Cercek, MD; Phone Number: 646-888-4189
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Cancer Center @ Commack
      • Contact: Andrea Cercek, MD; Phone Number: 646-888-4189
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester
      • Contact: Andrew Cercek, MD; Phone Number: 646-888-4189
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Andrew Cercek, MD; Phone Number: 646-888-4189
    • New York, New York, United States, 10035
      • Recruiting
      • MSK at Ralph Lauren
      • Contact: Andrew Cercek, MD; Phone Number: 646-888-4189
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau
      • Contact: Andrea Cercek, MD; Phone Number: 646-888-4189

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Potential research subjects will be identified through the Center for Young Onset Gastrointestinal Cancer, a member of the patient's treatment team, the principal investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC). All study participants will be recruited from patients under the care of consenting professionals. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish a prospective database of patients with Young Onset Colorectal Cancer	from diagnosis through survivorship	1 year

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Estimated): July 22, 2025
• Study Completion (Estimated): July 22, 2025

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; young onset colorectal cancer; colorectal registry; 20-315
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20-315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No