Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04489238

Conditions

Colorectal Cancer

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Risk Factor Questionnaire

Study Details

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.

Conditions

Colorectal Cancer

Colorectal Carcinoma

Study ID

NCT04489238

Start date

Jul 22, 2020

Status verified date

Feb, 2026

Completion date

Jul 22, 2026

Anticipated

Primary completion date

Jul 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1366 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Risk Factor Questionnaire

Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit

Primary outcome measure

  • Establish a prospective database of patients with Young Onset Colorectal Cancer [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Andrea Cercek, MD

646-888-4189cerceka@mskcc.org

Rona Yaeger, MD

646-888-5109yaegerr@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Cancer Center @ Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Andrea Cercek, MD

646-888-4189

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Andrew Cercek, MD

646-888-4189

MSK at Ralph Lauren

Recruiting

New York, New York, United States, 10035

Contacts

Andrew Cercek, MD

646-888-4189

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Andrew Cercek, MD

646-888-4189

Memorial Sloan Kettering Nassau

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Andrea Cercek, MD

646-888-4189

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • young onset colorectal cancer
  • colorectal registry
  • 20-315
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-06.