Collection of Information to Better Understand Young Onset Colorectal Cancer

Recruiting

• Conditions: Colorectal Carcinoma; Colorectal Cancer
• Interventions: Other: Risk Factor Questionnaire

• Registration Number: NCT04489238
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-07-22
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-19
• Primary Completion: 2025-07-22
• Study Completion: 2025-07-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1366

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young onset Colorectal Cancer Participants	Risk Factor Questionnaire	(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	Risk Factor Questionnaire	(Stool collection cohort only) 166 colorectal cancer patients 50 year-old or older will serve as controls. Stool collection cohort only.

Primary Outcome Measures

Name	Time	Method
Establish a prospective database of patients with Young Onset Colorectal Cancer	1 year	from diagnosis through survivorship

Trial Locations

Locations (8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

MSK at Ralph Lauren; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Rockville Centre, New York, United States