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"

Exact Sciences Corporation

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Blood Sample Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04144751

2019-01B

Details and patient eligibility

About

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 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.

Enrollment: 23,494 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

23,494 participants in 1 patient group

Subjects Enrolled in 2019-01 BLUE-C

Description:

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.

Treatment:

Other: Blood Sample Collection