Collection of Information to Better Understand Young Onset Colorectal Cancer

NCT ID: NCT04489238

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1366 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-22

Study Completion Date

2026-07-22

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Colorectal Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Risk Factor Questionnaire

Intervention Type OTHER

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

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.

Risk Factor Questionnaire

Intervention Type OTHER

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

Interventions

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Risk Factor Questionnaire

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

Intervention Type OTHER

Other Intervention Names

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CYOC Risk Factor Questionnaire

Eligibility Criteria

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Inclusion Criteria

* 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)


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Cercek, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

MSK at Ralph Lauren

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea Cercek, MD

Role: CONTACT

646-888-4189

Rona Yaeger, MD

Role: CONTACT

646-888-5109

Facility Contacts

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Andrea Cercek, MD

Role: primary

646-888-4189

Andrea Cercek, MD

Role: primary

646-888-4189

Andrea Cercek, MD

Role: primary

646-888-4189

Andrea Cercek, MD

Role: primary

646-888-4189

Andrew Cercek, MD

Role: primary

646-888-4189

Andrew Cercek, MD

Role: primary

646-888-4189

Andrew Cercek, MD

Role: primary

646-888-4189

Andrea Cercek, MD

Role: primary

646-888-4189

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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20-315

Identifier Type: -

Identifier Source: org_study_id

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