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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" | Clinical Trials | Clareo Health

COMPLETED

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"

NCT04144751•Exact Sciences Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

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.

Locations (194)

Parkway Medical Center

Birmingham, Alabama, United States

Summit Internal Medicine, PC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

G & L Research

Foley, Alabama, United States

Medical Affiliated Research Center

Huntsville, Alabama, United States

East View Medical Research, LLC

Mobile, Alabama, United States

GI Associates of West Alabama, P.C

Tuscaloosa, Alabama, United States

Mayo Clinic - AZ

Phoenix, Arizona, United States

Key Dates

Start Date

November 15, 2019

Primary Completion Date

March 30, 2023

Completion Date

March 30, 2023

Last Updated

September 28, 2023

Enrollment

23,494

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Blood Sample Collection

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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"

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease