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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