Colorectal CancerNCT04489238
Collection of Information to Better Understand Young Onset Colorectal Cancer
An observational study of Colorectal Cancer and Colorectal Carcinoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Carcinoma
- What is being tested?
- Risk Factor Questionnaire
- How many people
- 1,366 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Jul 2020to 22 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York, 11725
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Andrew Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Andrea Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Andrea Cercek, MD, 646-888-4189
- Recruiting
MSK at Ralph Lauren
New York, New York, 10035
Andrew Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Andrew Cercek, MD, 646-888-4189
- Recruiting
Memorial Sloan Kettering Nassau
Rockville Centre, New York, 11553
Andrea Cercek, MD, 646-888-4189
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Colorectal Carcinoma
- Being tested
- Risk Factor Questionnaire
- Keywords
- young onset colorectal cancer, colorectal registry, 20-315, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Factor QuestionnaireOther
Also called CYOC Risk Factor Questionnaire
Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Risk Factor Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a prospective database of patients with Young Onset Colorectal Cancer
from diagnosis through survivorship
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start22 Jul 2020
- Primary completion22 Jul 2027 (estimated)
- Study completion22 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,366 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Cercek, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489238
- Sponsor's protocol ID
- 20-315
- Status last verified
- Feb 2026
- First submitted
- 23 Jul 2020
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.