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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130017 S029/ PAS001 |
| Date Original Protocol Accepted |
09/20/2019
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| Date Current Protocol Accepted |
08/26/2020
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| Study Name |
A Post-Marketing Real World Study-Tidal
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| Device Name |
Cologuard Stool DNA-Based Colorectal Cancer Screening Test
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Other Data Source
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective is to evaluate the performance of Cologuard for CRC screening in patients under the age of 50 by collecting real world data on subsequent CRC screening and CRC-related outcomes.
This post-approval observational study is a largely automated multi-center study that will collect data from Integrated Delivery Networks (IDNs), hospital systems, and large primary care practices to generate a longitudinal record of patients’ journeys prior to and following an initial Cologuard screening. This approach relies on technology-based data collection to eliminate the need for ongoing manual data collection, abstraction, entry, and cleaning at the site level and ensures that all eligible patients are enrolled.
The study will leverage digitized data from structured and unstructured fields (e.g., pathology reports) from multiple sources and systems [e.g., EMR, ambulatory procedure centers (for colonoscopies), laboratory data, pathology information].
It is anticipated that at least 50,000 eligible patients under the age of 50 at the time of routine screening with Cologuard will be included in the study. Both Cologuard-positive and Cologuard-negative patients will be followed for subsequent CRC assessments and CRC-related outcomes.
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| Study Population |
All patients under the age of 50 undergoing CRC screening with a completed Cologuard test as part of routine clinical monitoring at each site, regardless of risk status, will be eligible for inclusion. Patients considered off-label, such as those meeting high-risk criteria and/or less than 45 years of age at the time of screening will be included and analyzed separately. Patients with orders for Cologuard but no recorded results will be excluded.
Data from the EMR will be used to determine risk status after the patient is included in the study. Patients will be considered high risk based on the presence of any of the following:
History of CRC, advanced adenoma, or other related cancer
Inflammatory bowel disease (IBD)
Chronic ulcerative colitis (CUC)
Crohn’s disease
Familial adenomatous polyposis (FAP)
Relevant familial hereditary cancer syndromes
Family history of CRC
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| Sample Size |
At least 50,000 patients will be included, which is anticipated to yield 12 CRC cases. If by chance no CRC cases are identified in the first 50,000 enrollees, the study will continue to accrue patients until at least one CRC case is identified in the patient population. Based on preliminary studies, a positive Cologuard rate of approximately 7% (n=~3500) is expected.
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| Key Study Endpoints |
The following outomes will be evaluated:
Cologuard positivity rate
Compliance to diagnostic colonoscopy within 12 months
CRC detected on colonoscopy following a positive Cologuard result
Advanced adenomas on colonoscopy following a positive Cologuard result
Non-advanced findings or no findings on colonoscopy following a positive Cologuard result
Observed specificity
CRC-related diagnoses within 36 months of a negative Cologuard result
Observed sensitivity
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| Follow-up Visits and Length of Follow-up |
Total study duration is estimated at 72 months, depending on the rate of uptake of Cologuard in the target population. For patients with a positive Cologuard result, at least 12 months of follow-up after the patient index date (initial Cologuard screening date) will be evaluated for colonoscopy results. For patients with a negative Cologuard result, at least 36 months of follow-up after the index date will be evaluated to ensure capture of potential positive CRC cases.
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