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"
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|ClinicalTrials.gov Identifier: NCT04144751|
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : September 20, 2021
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Other: Blood Sample Collection|
|Study Type :||Observational|
|Estimated Enrollment :||12500 participants|
|Official Title:||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"|
|Actual Study Start Date :||November 15, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
- Blood-based biomarkers associated with genetic and epigenetic alterations. [ Time Frame: Point in time blood collection (1 day) at enrollment ]
Biospecimen Retention: Samples With DNA
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): NCT04144751
|Contact: Alisa Hewittemail@example.com|
|Contact: Dania Brooksfirstname.lastname@example.org|
|Principal Investigator:||Thomas Imperiale, MD||Indiana University|