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"
- Conditions
- Colorectal Cancer
- Registration Number
- NCT04144751
- Lead Sponsor
- Exact Sciences Corporation
- Brief Summary
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).
- Detailed Description
Subjects who consent to enroll in Exact Sciences Protocol 2019-01 BLUE-C, will be invited to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2019-01 BLUE-C, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23494
- 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.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood-based biomarkers associated with genetic and epigenetic alterations. Point in time blood collection (1 day) at enrollment
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (187)
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
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
Scroll for more (177 remaining)Parkway Medical Center🇺🇸Birmingham, Alabama, United States