Collection of Information to Better Understand Young Onset Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Young Onset Gastrointestinal Cancer Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489238
• Other study ID #: 20-315
• Status: Recruiting
• Start date: July 22, 2020
• Est. completion date: July 22, 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Andrea Cercek, MD
• Phone: 646-888-4189
• Email: cerceka[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1366
• Est. completion date: July 22, 2025
• Est. primary completion date: July 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Risk Factor Questionnaire
Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	MSK at Ralph Lauren	New York	New York
United States	Memorial Sloan Kettering Nassau	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a prospective database of patients with Young Onset Colorectal Cancer	from diagnosis through survivorship	1 year

External Links

•   Memorial Sloan Kettering Cancer Center