Clinical trial NCT04489238: Collection of Information to Better Understand Young Onset Colorectal Cancer
Official title: Young Onset Gastrointestinal Cancer Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Carcinoma
Keywords: young onset colorectal cancer
colorectal registry
20-315
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 1366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Establish a prospective database of patients with Young Onset Colorectal Cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: MSK at Ralph Lauren
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Cercek, MD
role: PRINCIPAL_INVESTIGATOR
References: