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”
Overview
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).
Full Title of Study: “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””
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: March 30, 2023
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.
Interventions
- Other: Blood Sample Collection
- Subjects participating in the study will have blood drawn at enrollment.
Arms, Groups and Cohorts
- Subjects Enrolled in 2019-01 BLUE-C
- Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Subjects will provide a blood sample at time of enrollment.
Clinical Trial Outcome Measures
Primary Measures
- Blood-based biomarkers associated with genetic and epigenetic alterations.
- Time Frame: Point in time blood collection (1 day) at enrollment
Participating in This Clinical Trial
Inclusion Criteria
1. Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C. 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.
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Exact Sciences Corporation
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Thomas Imperiale, MD, Principal Investigator, Indiana University
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