A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

April 1, 2020 updated by: Exact Sciences Corporation

A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.

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

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.

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.
2404

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
      • Glendale, Arizona, United States, 85308
        • Thomas C Lenzmeier, M.D., P.C
      • Mesa, Arizona, United States, 85206
        • Central Arizona Medical Associates, PC
      • Tempe, Arizona, United States, 85283
        • Fiel Family and Sports Medicine
    • California
      • Carlsbad, California, United States, 92008
        • Cassidy Medical Group/Radiant Research, Inc.
      • Corona, California, United States, 92879
        • Kindred Medical Institute for Clinical Trials, LLC
      • Garden Grove, California, United States, 92840
        • Paragon RX Clinical
      • Los Angeles, California, United States, 90095
        • UCLA, Division of Digestive Diseases
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
      • Newport Beach, California, United States, 92663
        • John D. Homan, MD
      • Oxnard, California, United States, 93030
        • Diverse Research Solutions
      • Oxnard, California, United States, 93030
        • Ventura County Gastroenterology
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare Medical Group
      • Sacramento, California, United States, 95825
        • Advanced Pain Diagnostics & Solutions
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida
      • Homestead, Florida, United States, 33030
        • Homestead Medical Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc
      • Lauderdale Lakes, Florida, United States, 33319
        • Precision Clinical Research
      • Miami, Florida, United States, 33144
        • Next Phase Research Alliance
      • Miami, Florida, United States, 33134
        • Advanced Bioresearch
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center Of Florida
      • Port Saint Lucie, Florida, United States, 34984
        • Health Awareness, Inc-Port St. Lucie
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • The Kaufmann Clinic, Inc.
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Pharmakon Inc
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University, Eskanazi Hospital, Regenstrief Health Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Columbia Medical Practice
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Associates
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Nevada Family Care
    • New York
      • Binghamton, New York, United States, 13901
        • United Medical Associates
      • Endwell, New York, United States, 13760
        • Regional Clinical Research, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Sentral Clinical Research
      • Wooster, Ohio, United States, 44691
        • Comprehensive Internal Medicine, Inc.
      • Wooster, Ohio, United States, 45150
        • Family Practice Center of Wooster, Inc./Clinical Trial Developers
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Harleysville Medical Associates
    • Texas
      • Austin, Texas, United States, 78759
        • Austin Regional Clinic
      • Montgomery, Texas, United States, 77356
        • PCP for Life (DM Research)
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical 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

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will enroll approximately 2,400 men and women aged 50 years and older at a minimum of 20 sites to achieve a minimum of 1,119 subjects at the Year 3 visit. To increase the point prevalence of CRC in the study population, subject enrollment will be age-weighted toward a slightly older population. Enrollment of at least 65% of subjects age 65 years or older will be targeted

Description

Inclusion Criteria:

  1. Subject has been prescribed Cologuard for colorectal cancer screening
  2. Subject is at average risk for development of colorectal cancer
  3. Subject is 50 years or older
  4. Subject willing and able to sign informed consent.

Exclusion Criteria:

  1. Subject had a colonoscopy in the previous 9 years
  2. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
  3. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.
  4. Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
  5. Subject has a history of colorectal cancer or advanced adenoma.
  6. Subject has a history of aerodigestive tract cancer
  7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
  8. Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)

  9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:

    • Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
    • 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
    • One first-degree relative with CRC diagnosed before the age of 60.

  10. Subject has a family history of:

    • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
    • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

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: Other
  • Time Perspectives: Prospective

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
Measure Description
Time Frame
Positive and Negative Predictive Value
Time Frame: Three years
The difference between the positive predictive value (PPV) at year 3 (PPV3) and 1 minus the negative predictive value (NPV) at year 3 (NPV3).
Three years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Colorectal Cancer Incidence
Time Frame: 3 years
Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3)
3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive value of a positive Cologuard result at baseline (T0)
Time Frame: baseline
Predictive value of a positive Cologuard result at baseline (T0)
baseline
The predicative value of a positive and a negative Cologuard at year 3 (T3).
Time Frame: 3 years
The predicative value of a positive and a negative Cologuard at year 3 (T3).
3 years
The sensitivity and specificity of Cologuard at year 3 (T3).
Time Frame: 3 years
The sensitivity and specificity of Cologuard at year 3 (T3).
3 years
The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3).
Time Frame: 3 years
The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3).
3 years
The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR).
Time Frame: 3 years
The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR).
3 years
The probability that a negative Cologuard result at baseline remains negative through 3 years.
Time Frame: 3 years
The probability that a negative Cologuard result at baseline remains negative through 3 years.
3 years
The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years.
Time Frame: 3 years
The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years.
3 years
The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3
Time Frame: 3 years
The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3
3 years
Adherence to repeat Cologuard at year 3 (T3)
Time Frame: 3 years
Adherence to repeat Cologuard at T3 will be reported with counts and proportions.
3 years
Compliance to colonoscopy following a positive Cologuard result
Time Frame: baseline
Cumulative compliance to colonoscopy following a positive Cologuard result
baseline
Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3
Time Frame: Years 1, 2, and 3
Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3
Years 1, 2, and 3
The rate of no Cologuard result (e.g. invalid result)
Time Frame: 3 years
The rate of no Cologuard result (e.g. invalid result)
3 years
The adverse event rate (events occurring between collection kit distribution and sample submission)
Time Frame: 3 years
The adverse event rate (events occurring between collection kit distribution and sample submission)
3 years

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

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.
April 1, 2015

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 16, 2020

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 16, 2020

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).
April 9, 2015

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.
April 14, 2015

First Posted (Estimate)

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.
April 17, 2015

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.
April 2, 2020

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.
April 1, 2020

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.
April 1, 2020

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.
  • Exact Sciences 2014-01

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 deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.

IPD Sharing Time Frame

Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

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. Data will be available between 2 and 4 years after publication through the Sponsor.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

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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