Skip to main content
OpenTrials
Completed

NCT Number: NCT04144751

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"

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkway Medical Center, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.
  • Subject is willing and able to provide a blood sample.
  • Subject is willing and able to sign informed consent.

Exclusion criteria

  • Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Treatment and study plan

Blood Sample Collection

Other

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

Primary outcomes

  1. Blood-based biomarkers associated with genetic and epigenetic alterations.

    Time frame: Point in time blood collection (1 day) at enrollment

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2019
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.