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Trial record 1 of 1 for:    NCT04489238
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Collection of Information to Better Understand Young Onset Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04489238
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Carcinoma Other: Risk Factor Questionnaire

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 666 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Young Onset Gastrointestinal Cancer Prospective Registry
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : July 22, 2023
Estimated Study Completion Date : July 22, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
Other Name: CYOC 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
Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
Other Name: CYOC Risk Factor Questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. Establish a prospective database of patients with Young Onset Colorectal Cancer [ Time Frame: 1 year ]
    from diagnosis through survivorship


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489238


Contacts
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Contact: Andrea Cercek, MD 646-888-4189 cerceka@mskcc.org
Contact: Rona Yaeger, MD 646-888-5109 yaegerr@mskcc.org

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrea Cercek, MD    646-888-4189      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Andrea Cercek, MD    646-888-4189      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Andrea Cercek, MD    646-888-4189      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Andrea Cercek, MD    646-888-4189      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Andrew Cercek, MD    646-888-4189      
MSK at Ralph Lauren Recruiting
New York, New York, United States, 10035
Contact: Andrew Cercek, MD    646-888-4189      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Cercek, MD    646-888-4189      
Memorial Sloan Kettering Nassau Recruiting
Rockville Centre, New York, United States, 11553
Contact: Andrea Cercek, MD    646-888-4189      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Andrea Cercek, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04489238    
Other Study ID Numbers: 20-315
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
young onset colorectal cancer
colorectal registry
20-315
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases