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

May 12, 2021 updated by: Exact Sciences Corporation

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"

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

871

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Camarillo, California, United States, 93012
        • Ventura County Gastroenterology
      • Laguna Hills, California, United States, 92653
        • Alliance Research Centers
      • Oxnard, California, United States, 93030
        • FocilMed
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare Medical Group
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County
      • New Haven, Connecticut, United States, 06520
        • Yale University Section of Digestive Diseases and Liver Diseases
    • Florida
      • Lauderdale Lakes, Florida, United States, 33319
        • Precision Clinical Research, LLC
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System Evanston Hospital
      • Oak Lawn, Illinois, United States, 60453
        • DM Clinical Research- Southwest Gastroenterology
    • Indiana
      • Evansville, Indiana, United States, 47725
        • Deaconess Clinic- Mt. Pleasant
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic- Gateway
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County ClinTrials, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institue
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners, LLC
      • Shreveport, Louisiana, United States, 71103
        • Louisiana Research Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Investigative Clinical Research
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
      • Rockville, Maryland, United States, 20850
        • Capitol Research
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Commonwealth Clinical Studies
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New York
      • Binghamton, New York, United States, 13901
        • United Medical Associates
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
      • Wilmington, North Carolina, United States, 28403
        • Wilmington Gastroenterology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Wooster, Ohio, United States, 44691
        • Comprehensive Internal Medicine, Inc.
      • Wooster, Ohio, United States, 45150
        • Family Practice Center of Wooster, Inc./Clinical Trial Developers
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Gastroenterology Associates, PA
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research, PLLC
    • Texas
      • Austin, Texas, United States, 78726
        • Austin Regional Clinic
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center- McGovern Medical School
      • Houston, Texas, United States, 77070
        • DM Clinical Research- PCP for Life
    • Virginia
      • Suffolk, Virginia, United States, 23434
        • Virginia Gastroenterology Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Up to 942 subjects will be enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subject aged 45-49 with Average CRC Risk
Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Sciences Corporation

Investigators

  • Principal Investigator: Thomas Imperiale, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2018

Primary Completion (ACTUAL)

April 5, 2019

Study Completion (ACTUAL)

April 5, 2019

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-10B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figured, and appendices. The study protocol and informed consent form will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

IPD Sharing Time Frame

Data will be available from 2 years and ending 4 years after publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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