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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"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144751
Recruitment Status : Active, not recruiting
First Posted : October 30, 2019
Last Update Posted : February 27, 2023
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Study Description
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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).

Condition or disease Intervention/treatment
Colorectal Cancer Other: Blood Sample Collection

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 24000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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"
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects Enrolled in 2019-01 BLUE-C
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.
 Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.


Outcome Measures
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Primary Outcome Measures :
  1. Blood-based biomarkers associated with genetic and epigenetic alterations. [ Time Frame: Point in time blood collection (1 day) at enrollment ]

Biospecimen Retention:   Samples With DNA
Blood samples may be used for evaluating performance of biomarkers for feasibility and assay development. Sample may be stored for up to 20 years. These blood samples will be de-identified.

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Up to 24,000 subjects will be enrolled.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144751


Locations
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Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Principal Investigator: Thomas Imperiale, MD Indiana University
More Information
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT04144751    
Other Study ID Numbers: 2019-01B
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications of the study may be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol and informed consent form may also be shared. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data may be available from 2 years and ending 4 years after publication.
Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Exact Sciences Corporation:
Blood Draw
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases