Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"

Completed

Conditions studied: Colorectal Cancer

In brief

The primary objective of this sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).

Key facts

Study ID

NCT04144751

Run by

Exact Sciences Corporation

People needed

23494

Starts

2019-11-15

Expected to finish

2023-03-30

Last updated by the study team

2023-09-28

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.
• Subject is willing and able to provide a blood sample.
• Subject is willing and able to sign informed consent.

You may not qualify if…

• Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Where it is running

• Summit Internal Medicine, PC — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cullman Clinical Trials — Cullman, Alabama, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• G & L Research — Foley, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• East View Medical Research, LLC — Mobile, Alabama, United States
• GI Associates of West Alabama, P.C — Tuscaloosa, Alabama, United States
• Mayo Clinic - AZ — Phoenix, Arizona, United States
• Del Sol Research Management, LLC — Tucson, Arizona, United States
• Southern Arizona VA Health Care System (SAVAHCS) — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Arkansas Gastroenterology, P.A. — North Little Rock, Arkansas, United States
• Fomat Medical Research — Camarillo, California, United States
• Alliance Research Institute — Canoga Park, California, United States
• GW Research Inc — Chula Vista, California, United States
• Paragon Rx Clinical, Inc. — Garden Grove, California, United States
• United Medical Doctors — Irvine, California, United States
• Prime Care Clinical Research Center — Laguna Hills, California, United States
• Gastro Care Institute — Lancaster, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Knowledge Research Center — Orange, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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