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"
1 other identifier
observational
871
1 country
37
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedStudy Start
First participant enrolled
November 8, 2018
CompletedFirst Posted
Study publicly available on registry
November 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2019
CompletedMay 17, 2021
May 1, 2021
5 months
October 31, 2018
May 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood-based biomarkers associated with genetic and epigenetic alterations.
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
Study Arms (1)
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.
Interventions
Subjects participating in the study will have blood drawn at enrollment.
Eligibility Criteria
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.
You may qualify if:
- Subject is currently enrolled in Exact Sciences Protocol 2018-10
- Subject is willing and able to provide a blood sample.
- Subject is willing and able to sign informed consent.
You may not qualify if:
- \. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Ventura County Gastroenterology
Camarillo, California, 93012, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Focilmed
Oxnard, California, 93030, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Yale University Section of Digestive Diseases and Liver Diseases
New Haven, Connecticut, 06520, United States
Precision Clinical Research, LLC
Lauderdale Lakes, Florida, 33319, United States
Northshore University Health System Evanston Hospital
Evanston, Illinois, 60201, United States
DM Clinical Research- Southwest Gastroenterology
Oak Lawn, Illinois, 60453, United States
Deaconess Clinic- Mt. Pleasant
Evansville, Indiana, 47725, United States
Deaconess Clinic- Gateway
Newburgh, Indiana, 47630, United States
Johnson County ClinTrials, LLC
Lenexa, Kansas, 66219, United States
New Orleans Research Institue
Metairie, Louisiana, 70006, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center
Shreveport, Louisiana, 71103, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Capitol Research
Rockville, Maryland, 20850, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
United Medical Associates
Binghamton, New York, 13901, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Comprehensive Internal Medicine, Inc.
Wooster, Ohio, 44691, United States
Family Practice Center of Wooster, Inc./Clinical Trial Developers
Wooster, Ohio, 45150, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29615, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research, PLLC
Nashville, Tennessee, 37211, United States
Austin Regional Clinic
Austin, Texas, 78726, United States
University of Texas Health Science Center- McGovern Medical School
Houston, Texas, 77030, United States
DM Clinical Research- PCP for Life
Houston, Texas, 77070, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Biospecimen
Residual 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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Imperiale
Indiana University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 14, 2018
Study Start
November 8, 2018
Primary Completion
April 5, 2019
Study Completion
April 5, 2019
Last Updated
May 17, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will 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.
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.