Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.
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|ClinicalTrials.gov Identifier: NCT03741166|
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment|
|Colo-rectal Cancer||Other: Blood Sample Collection|
|Study Type :||Observational|
|Actual Enrollment :||842 participants|
|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"|
|Actual Study Start Date :||November 8, 2018|
|Actual Primary Completion Date :||April 5, 2019|
|Actual Study Completion Date :||April 5, 2019|
Subject aged 45-49 with Average CRC Risk
Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. 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 ]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.
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): NCT03741166
Show 37 Study Locations
|Principal Investigator:||Thomas Imperiale||Indiana University|
|Study Director:||Natalia Voge, MD, PhD||Exact Sciences|