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NCT03741166 Clinical Trial

Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.

Colo-rectal Cancer Clinical Trial

Official title:
Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: "An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03741166
Other study ID # 2018-10B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2018
Est. completion date April 5, 2019

Study information
Verified date May 2021
Source Exact Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).

Description:

Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Recruitment information / eligibility
Status Completed
Enrollment 871
Est. completion date April 5, 2019
Est. primary completion date April 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 49 Years
Eligibility Inclusion Criteria: 1. Subject is currently enrolled in Exact Sciences Protocol 2018-10 2. Subject is willing and able to provide a blood sample. 3. Subject is willing and able to sign informed consent. Exclusion Criteria: 1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.

Locations
Country Name City State
United States Investigative Clinical Research Annapolis Maryland
United States Asheville Gastroenterology Associates Asheville North Carolina
United States Austin Regional Clinic Austin Texas
United States United Medical Associates Binghamton New York
United States Gastroenterology Associates of Fairfield County Bridgeport Connecticut
United States Commonwealth Clinical Studies Brockton Massachusetts
United States Ventura County Gastroenterology Camarillo California
United States Charlotte Gastroenterology & Hepatology, PLLC Charlotte North Carolina
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Centennial Medical Group Elkridge Maryland
United States Northshore University Health System Evanston Hospital Evanston Illinois
United States Deaconess Clinic- Mt. Pleasant Evansville Indiana
United States Gastro One Germantown Tennessee
United States Gastroenterology Associates, PA Greenville South Carolina
United States DM Clinical Research- PCP for Life Houston Texas
United States University of Texas Health Science Center- McGovern Medical School Houston Texas
United States Alliance Research Centers Laguna Hills California
United States Precision Clinical Research, LLC Lauderdale Lakes Florida
United States Johnson County ClinTrials, LLC Lenexa Kansas
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States New Orleans Research Institue Metairie Louisiana
United States Wisconsin Center for Advanced Research Milwaukee Wisconsin
United States Delta Research Partners, LLC Monroe Louisiana
United States Quality Medical Research, PLLC Nashville Tennessee
United States Yale University Section of Digestive Diseases and Liver Diseases New Haven Connecticut
United States Deaconess Clinic- Gateway Newburgh Indiana
United States DM Clinical Research- Southwest Gastroenterology Oak Lawn Illinois
United States Focilmed Oxnard California
United States Desert Oasis Healthcare Medical Group Palm Springs California
United States Mayo Clinic Arizona Phoenix Arizona
United States Mayo Clinic Rochester Rochester Minnesota
United States Capitol Research Rockville Maryland
United States Louisiana Research Center Shreveport Louisiana
United States Virginia Gastroenterology Institute Suffolk Virginia
United States Wilmington Gastroenterology Associates Wilmington North Carolina
United States Comprehensive Internal Medicine, Inc. Wooster Ohio
United States Family Practice Center of Wooster, Inc./Clinical Trial Developers Wooster Ohio

Sponsors (1)
Lead Sponsor Collaborator
Exact Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood-based biomarkers associated with genetic and epigenetic alterations. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer. Point in time blood collection (1 day) at enrollment
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