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

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ClinicalTrials.gov Identifier: NCT02419716
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

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

Condition or disease Intervention/treatment
Colorectal Cancer Screening Colorectal Cancer Device: Cologuard

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.

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Study Type : Observational
Actual Enrollment : 2404 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
Study Start Date : April 2015
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Cologuard
    Prescription of Cologuard for at-home stool collection


Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Colorectal Cancer Incidence [ Time Frame: 3 years ]
    Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3)


Other Outcome Measures:
  1. Predictive value of a positive Cologuard result at baseline (T0) [ Time Frame: baseline ]
    Predictive value of a positive Cologuard result at baseline (T0)

  2. 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. The sensitivity and specificity of Cologuard at year 3 (T3). [ Time Frame: 3 years ]
    The sensitivity and specificity of Cologuard at year 3 (T3).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. Compliance to colonoscopy following a positive Cologuard result [ Time Frame: baseline ]
    Cumulative compliance to colonoscopy following a positive Cologuard result

  11. 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

  12. The rate of no Cologuard result (e.g. invalid result) [ Time Frame: 3 years ]
    The rate of no Cologuard result (e.g. invalid result)

  13. 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)


Biospecimen Retention:   Samples With DNA
A portion of the stool sample may be retained, if any remains after the study-related tests for use in a sample bank for use in the future. The samples may be stored for up to twenty (20) years. These stool samples will de-identified.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

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): NCT02419716


Locations
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Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Principal Investigator: Thomas Imperiale, MD Indiana University
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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT02419716    
Other Study ID Numbers: Exact Sciences 2014-01
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
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 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.
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.
Keywords provided by Exact Sciences Corporation:
colorectal cancer
Colorectal cancer screening
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