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|
| General |
| Study Status |
Hold |
Application Number /
Requirement Number |
P130001 / PAS001 |
| Date Original Protocol Accepted |
10/18/2016
|
| Date Current Protocol Accepted |
|
| Study Name |
Epi proColon PAS
|
| Device Name |
Epi proColon
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a single arm, prospective, multi-center, longitudinal,
new enrollment study designed to evaluate the performance of the Epi proColon test by the following measures: test accuracy, longitudinal adherence to Epi proColon screening, adherence
to follow-up colonoscopy, diagnostic yield, and assay failure.
These are to be assessed in a population of patients at average risk for colorectal cancer, who after appropriate counseling from their healthcare provider, have been offered and declined screening by fecal occult blood testing and colonoscopy.
The primary objectives are:
a) To demonstrate that the proportion of subjects with a positive test (EPC+) result at Time 1 (T1), but without colorectal cancer as assessed by colonoscopy (D-), i.e., PrT1 (D-, EPC +), is significantly less than the proportion of subjects at baseline/Time zero (T0) with a positive test result but without colorectal cancer, PrT0 (D-, EPC +).
b) To demonstrate the Epi proColon detects colorectal cancer at T1 in patients that tested negative at T0.
|
| Study Population |
Adults of either sex, 50 years or older (but younger than 75), defined as average risk for CRC, who have been offered and have a history of not completing CRC screening.
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| Sample Size |
The sample size was determined based on a probability between 85 and 94% of being able to detect a colorectal cancer positive patient at T1 (assuming that patient tested negative at T0) using the Epi proColon test. It was determined that 4500 subjects would need to be enrolled. Additional assumptions included the estimated prevalence of colorectal cancer at T0 (0.6%), the estimated sensitivity (0.68) and specificity (0.82) at T0, a T1 return rate (between 66% and 80%), the estimated sensitivity (0.50) and specificity (0.88) at T1, and an estimated adherence to follow-up colonoscopy (between 66% and 80%).
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| Key Study Endpoints |
The primary endpoints are
the proportion of participants at T1 with a positive test result, but without colorectal cancer
the proportion of subjects at the first screening (T0) with a positive test result, but without colorectal cancer
colorectal cancer detection via Epi proColon test at T1 in patients tested negative via Epi proColon at T0.
The secondary endpoints are
the cumulative probability of cancer detection
the cumulative probability of a false referral
the probability of testing negative at both time points
the adherence to Epi proColon at both screenings (i.e., T0, T1)
the diagnostic yield
the adherence to follow-up diagnostic colonoscopy after a positive Epi proColon test
the assay failure rate
adverse events related to blood draw
adverse events related to diagnostic colonoscopy
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed for up to 21 months.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2956
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| Actual Number of Sites Enrolled |
5
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| Patient Follow-up Rate |
As of March 31, 2023, 2956 subjects have been enrolled since the study start, with the testing of the samples performed at four designated laboratories. Out of 2956 Subjects enrolled, 49 subjects have been excluded from analysis.
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