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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Cologuard PAS


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General
Application Number P130017 / PAS001
Current Plan Approved 09/25/2015
Study Name OSB Lead-Cologuard PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study objective is to collect longitudinal data on subjects for whom Cologuard is used over the course of 3 years. It is a prospective, longitudinal, multi-center study.
Study Population Description The study population is defined with the following criteria: Subjects must meet the following criteria to be eligible for the study:

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.

5. Subjects not listed in the exclusion criteria, described in 6.2 of the protocol.

Sample Size A total of 2,173 subjects will be enrolled to have 1,119 subjects at the year 3 visit (T3) for the Cologuard evaluation assuming

16.1% positivity rate at T0, with 15% annualized lost to follow up (LTFU). Further, it is assumed that 15% of the 1,119 subjects will refuse T3 colonoscopy to result in 951 being evaluable for T3 analyses.

Data Collection The primary endpoint for this study is the difference between the positive predictive value (PPV) at T3 (PPV3) and 1 minus the negative predictive value (NPV) at T3 (NPV3).

The secondary endpoint is the observed vs. the expected reduction in CRC incidence at T3.

Other outcomes to be assessed include the following:

¿The predictive values of a positive Cologuard at T0 and T3 and of a negative Cologuard atT3;

¿The sensitivity and specificity of Cologuard at T3;

¿The positive (PLR) and negative (NLR) likelihood ratios at T3;

¿The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result

¿(cTPR);

¿The probability that a negative Cologuard result at baseline remains negative through 3 years;

¿The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years;

¿The distribution of colorectal epithelial lesions overall and among positive Cologuard subjects at T0 and

¿T3 will be reported with counts and proportions;

¿The rate of adherence to repeat Cologuard at T3 will be reported with counts and proportions;

¿The Cumulative compliance to Colonoscopy following a positive Cologuard result

¿The rate of crossover to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1

and T2;

¿The rate of no Cologuard result (e.g. invalid result); and

¿The adverse event rate (events occurring between collection kit distribution and sample submission).

Follow-up Visits and Length of Follow-up Study participants will be followed for 3 years


OSB Lead-Cologuard PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/09/2015 02/24/2015 Overdue/Received
one year report 08/11/2015 08/07/2015 On Time
18 month report 02/09/2016 02/04/2016 On Time
two year report 08/10/2016 08/09/2016 On Time
three year report 08/10/2017    
four year report 08/10/2018    
five year report 08/10/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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