NCT04489238

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,366

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2020Jul 2026

Study Start

First participant enrolled

July 22, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

July 23, 2020

Last Update Submit

February 4, 2026

Conditions

Keywords

young onset colorectal cancercolorectal registry20-315Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Establish a prospective database of patients with Young Onset Colorectal Cancer

    from diagnosis through survivorship

    1 year

Study Arms (2)

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

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

Interventions

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

Also known as: CYOC Risk Factor Questionnaire
Average onset Colorectal Cancer ParticipantsYoung onset Colorectal Cancer Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Histological or cytological diagnosis of gastrointestinal cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

MSK at Ralph Lauren

New York, New York, 10035, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Andrea Cercek, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Cercek, MD

CONTACT

Rona Yaeger, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 28, 2020

Study Start

July 22, 2020

Primary Completion (Estimated)

July 22, 2026

Study Completion (Estimated)

July 22, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Locations