Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03741166

Enrollment

871

Registered

2018-11-14

Start date

2018-11-08

Completion date

2019-04-05

Last updated

2021-05-17

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

Conditions

Colo-rectal Cancer

Keywords

Blood Draw

Brief summary

The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).

Detailed description

Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subject is currently enrolled in Exact Sciences Protocol 2018-10 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

Measure	Time frame	Description
Blood-based biomarkers associated with genetic and epigenetic alterations.	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.

Countries

United States

Outcome results

None listed

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