Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04144751
Enrollment
23494
Registered
2019-10-30
Start date
2019-11-15
Completion date
2023-03-30
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Blood Draw

Brief summary

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).

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

OTHERBlood Sample Collection

Subjects participating in the study will have blood drawn at enrollment.

Sponsors

Exact Sciences Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Blood-based biomarkers associated with genetic and epigenetic alterations.Point in time blood collection (1 day) at enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026