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"

September 26, 2023 updated by: Exact Sciences Corporation
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23494

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Birmingham, Alabama, United States, 35243
        • Summit Internal Medicine, PC
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
      • Dothan, Alabama, United States, 36301
        • Digestive Health Specialists of the Southeast
      • Foley, Alabama, United States, 36535
        • G & L Research
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center
      • Mobile, Alabama, United States, 36608
        • East View Medical Research, LLC
      • Tuscaloosa, Alabama, United States, 35406
        • GI Associates of West Alabama, P.C
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - AZ
      • Tucson, Arizona, United States, 85712
        • Del Sol Research Management, LLC
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System (SAVAHCS)
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Lynn Institute of the Ozarks
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology, P.A.
    • California
      • Camarillo, California, United States, 93012
        • Fomat Medical Research
      • Canoga Park, California, United States, 91304
        • Alliance Research Institute
      • Chula Vista, California, United States, 91910
        • GW Research Inc
      • Garden Grove, California, United States, 92840
        • Paragon RX Clinical, Inc.
      • Irvine, California, United States, 92618
        • United Medical Doctors
      • Laguna Hills, California, United States, 92656
        • Prime Care Clinical Research Center
      • Lancaster, California, United States, 93534
        • Gastro Care Institute
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Orange, California, United States, 92868
        • Knowledge Research Center
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare Medical Group
      • Palo Alto, California, United States, 34304
        • Palo Alto Veterans Institute for Research
      • San Diego, California, United States, 92103
        • SDG Clinical Research
      • San Jose, California, United States, 95116
        • San Jose Gastroenterology
      • Santa Ana, California, United States, 92703
        • Paragon Rx Clinical, Inc. - Santa Ana
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Sherman Oaks, California, United States, 91403
        • Unison Clinical Trials
      • Thousand Oaks, California, United States, 91360
        • Millennium Clinical Trials
      • Upland, California, United States, 91786
        • Dream Team Clinical Research
    • Colorado
      • Golden, Colorado, United States, 80401
        • New West Physicians
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Institute
      • New Haven, Connecticut, United States, 06519
        • Yale University
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Cornerstone Research Institute
      • Fort Myers, Florida, United States, 33907
        • Vanguard Clinical Research
      • Gainesville, Florida, United States, 32607
        • SIMED Health Research
      • Jacksonville, Florida, United States, 32205
        • Westside Center of Clinical Research
      • Jacksonville, Florida, United States, 32206
        • Shands Jacksonville Medical Center, Inc - University of Florida Health
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Lake City, Florida, United States, 32055
        • Wr-Msra, Llc
      • Lighthouse Point, Florida, United States, 33064
        • Alliance Medical Research
      • Miami, Florida, United States, 33156
        • Research Associates of South Florida, LLC
      • Miami, Florida, United States, 33144
        • Next Phase Research Alliance
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33176
        • Gastro Health Research
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
      • Ocala, Florida, United States, 34471
        • Sarkis Clinical Trials
      • Palmetto Bay, Florida, United States, 33157
        • IMIC, Inc.
      • Plant City, Florida, United States, 33563
        • Family Medical Specialists of Florida, PLC
      • Saint Petersburg, Florida, United States, 33711
        • Alternative Solutions, LLC
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research, LLC
      • Tampa, Florida, United States, 33614
        • Clinical Trials of Tampa
    • Georgia
      • Athens, Georgia, United States, 30607
        • Summit Clinical Research, LLC
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Decatur, Georgia, United States, 30033
        • Atlanta Center for Gastroenterology, P.C.
      • Morrow, Georgia, United States, 30260
        • Infinite Clinical Trials
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Illinois
      • Champaign, Illinois, United States, 61882
        • Christie Clinic
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Downers Grove, Illinois, United States, 60515
        • GI Partners of IL / Avicenna
      • Hines, Illinois, United States, 60141
        • Edward Hines Jr. VA Hospital
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc.
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic, Inc.
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic
    • Iowa
      • Ames, Iowa, United States, 50010
        • PMG Research
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, P.C.
    • Kansas
      • Galena, Kansas, United States, 66739
        • Digestive Health Center of the Four States, LLC
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic
      • Wichita, Kansas, United States, 67214
        • Ascension Via Christi Hospitals Wichita, Inc
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Healthcare
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group of Opelousas, LLC
      • Houma, Louisiana, United States, 70360
        • Houma Digestive Health Specialists-CroNOLA
      • Lafayette, Louisiana, United States, 70503
        • Combined Gastro Research. LLC
      • Lake Charles, Louisiana, United States, 70601
        • Clinical Trials of SWLA, LLC
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center; Gastrointestinal Associates
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America, LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Gastro Health Research
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center - Harvard
      • Cambridge, Massachusetts, United States, 02139
        • IQVIA RDS, Inc.
      • Chelmsford, Massachusetts, United States, 01824
        • Digestive Health Specialists, PC
      • Fall River, Massachusetts, United States, 02721
        • NECCR Primacare Research, LLC
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts - Worcester
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Troy, Michigan, United States, 48085
        • Oakland Medical Research Center
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health Research
      • Troy, Michigan, United States, 48085
        • Oakland Medical Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research LLC (STAR)
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Methodist Physicians Clinic / CCT Research
      • Omaha, Nebraska, United States, 68124
        • CHI Nebraska
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research of South Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada, Las Vegas
      • Reno, Nevada, United States, 89511
        • Digestive Health Associates
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
      • West Long Branch, New Jersey, United States, 07728
        • Allied Health Clinical Research Organization, LLC
    • New York
      • Binghamton, New York, United States, 13903
        • United Health Services Hospitals, Inc.
      • Brooklyn, New York, United States, 11209
        • VA NY Harbor HCS- Brooklyn Campus
      • Flushing, New York, United States, 11354
        • Sing Chan, MD
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • North Massapequa, New York, United States, 11758
        • DiGiovanna Institute for Medical Education & Research
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Digestive Health Partners, PA
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28210
        • Javara
      • Charlotte, North Carolina, United States, 28207
        • Atrium Health Department of Family Medicine Research
      • Fayetteville, North Carolina, United States, 28304
        • Coastal Research Institute, LLC
      • Greensboro, North Carolina, United States, 27408
        • Medication Management LLC
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Mount Airy, North Carolina, United States, 27030
        • Clinical Trials of America, LLC
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care, P.A
      • Wilmington, North Carolina, United States, 28403
        • Trial Management Associates, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Plains Clinical Research Center, LLC
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research, LLC
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Great Lakes Medical Research LLC
      • Cincinnati, Ohio, United States, 45224
        • Hightop Medical Research Center
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Dayton, Ohio, United States, 45409
        • Dayton Clinical Research
      • Dayton, Ohio, United States, 45432
        • META Medical Research Institute, LLC
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research and Consulting, Llc
      • Westlake, Ohio, United States, 44145
        • NorthShore Gastroenterology Research, LLC
      • Wooster, Ohio, United States, 44691
        • Comprehensive Internal Medicine, Inc
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research, LLC
      • Oklahoma City, Oklahoma, United States, 73102
        • SSM Health Medical Group/Hightower Clinical
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Great Lakes Medical Research, LLC
      • Johnstown, Pennsylvania, United States, 15905
        • Richard M. Kastelic, M.D., and Associates, P.C.
      • Lancaster, Pennsylvania, United States, 17601
        • Regional GI
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Philadelphia
      • Pottsville, Pennsylvania, United States, 17901
        • Care Access Research, Pottsville
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Pharmacorp Clinical Trials, Inc.
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VAMC
      • West Columbia, South Carolina, United States, 29169
        • Invocare Medical Research & Healthcare Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center, LLP
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch, LLC
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic, PA
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic, PA
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions, LLC - TN
      • Kingsport, Tennessee, United States, 37663
        • Tri-Cities Gastroenterology
      • Union City, Tennessee, United States, 38261
        • Great Lakes Medical Research, LLC
    • Texas
      • Austin, Texas, United States, 78745
        • ARC Clinical Research at William Cannon
      • Austin, Texas, United States, 78726
        • ARC Clinical Research at Four Points
      • Austin, Texas, United States, 78738
        • Elligo Health Research Inc
      • Austin, Texas, United States, 78748
        • Avant Research Associates
      • Dallas, Texas, United States, 75211
        • Mercy Family Clinic
      • Dallas, Texas, United States, 75235
        • Dharma PA D/B/A Southwest Family Medicine Associates
      • El Paso, Texas, United States, 79905
        • Texas Tech University Health Sciences Center El Paso
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, United States, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77030
        • Houston Digestive Disease
      • Houston, Texas, United States, 77087
        • Fairway Medical Clinic
      • Houston, Texas, United States, 77505
        • Digestive System Healthcare
      • Lampasas, Texas, United States, 76550
        • Fmc Science, Llc
      • McAllen, Texas, United States, 78503
        • Rio Grande Gastroenterology
      • McKinney, Texas, United States, 75071
        • Wellness Clinical Research
      • Pflugerville, Texas, United States, 78660
        • ARC Clinical Research at Kelly Lane
      • Red Oak, Texas, United States, 75154
        • Epic Medical Research LLC
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America
      • Sugar Land, Texas, United States, 77479
        • A & U Family Medicine
      • Tomball, Texas, United States, 77375
        • Texas Gastro Consultants
    • Utah
      • Bountiful, Utah, United States, 84010
        • Progressive Clinical Research, LLC
      • Layton, Utah, United States, 84041
        • Tanner Clinic
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
      • Riverton, Utah, United States, 84096
        • Granger Medical Clinic
      • Riverton, Utah, United States, 84065
        • Advanced Clinical Research
      • Sandy, Utah, United States, 84092
        • Advanced Research Institute
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
      • Petersburg, Virginia, United States, 23805
        • Summit Clinical Research
      • Richmond, Virginia, United States, 23249
        • Central Virginia VA Healthcare System
      • Suffolk, Virginia, United States, 23434
        • Virginia Gastroenterology Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute at Virginia Mason
      • Spokane, Washington, United States, 99202
        • Spokane Gastroenterology
      • Wenatchee, Washington, United States, 98801
        • Wentachee Valley Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • University Physicians and Surgeons, Inc.(Marshall Health)
    • Wisconsin
      • Madison, Wisconsin, United States, 53215
        • University of Wisconsin Hospital and Clinics
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

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.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Blood-based biomarkers associated with genetic and epigenetic alterations.
Time Frame: Point in time blood collection (1 day) at enrollment
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Exact Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Imperiale, MD, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-01B

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 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.

IPD Sharing Time Frame

Data may 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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