Date: 2015-05-08
Type of information: Results
phase:
Announcement: results
Company: Epigenomics (Germany - USA)
Product: Epi proColon® (colorectal cancer blood test)
Action mechanism:
Disease: colorectal cancer
Therapeutic area: Cancer - Oncology - Diagnostic
Country: USA
Trial
details: This study is designed to investigate the relative participation in CRC screening in average risk, screening eligible patients with demonstrated non-adherence to guideline-recommended screening modalities. Participation with the fecal immunochemical test (FIT) and the blood-based Epi proColon® test will be examined. Screening eligible average-risk patients identified as non-adherent by medical record will be eligible for the study. Potential subjects will be recruited to participate in a study via mailing and/or at a clinic visit. All study subjects will be enrolled at a clinic visit and will be randomized in two study arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be compared between those that accept and complete the blood test and those that accept and complete the FIT test. A passive control, usual care arm will comprise subjects meeting eligibility criteria, but not recruited for or participating in the study. In conjunction with published data (Johnson et al, 2014), the relative utilization of the blood test will be compared to the screening participation via FIT. Increased participation with the Epi proColon blood test could increase screening rates in the non-adherent population. Additionally, for those testing positive in the trial, the rate of adherence to colonoscopy will be determined. (NCT02251782)
Latest
news: * On May 8, 2015, Epigenomics announced results from the ADMIT trial (ADherence to Minimally Invasive Testing ) for its non-invasive blood-based test for colorectal cancer (CRC) screening, Epi proColon®. The study demonstrated a 99.5% rate of adherence to CRC screening using Epi proColon®, while the fecal immunochemical test (FIT) showed an adherence rate of 88.1%. These numbers contrast to a baseline adherence to standard of care CRC screening of less than 25%, as measured in a passive control arm in which previously non-compliant patients were offered CRC screening tests (FIT or colonoscopy) as part of their standard of care. Adherence to Epi proColon® was significantly greater than adherence to FIT, with an observed difference of 11.4% (p<0.0001). The study was designed to determine whether the adherence to Epi proColon® was significantly greater than to FIT plus a margin of 8.2%. This margin was determined before the study based on a projected FIT adherence rate. While adherence to Epi proColon® ultimately was higher than the FIT adherence plus 8.2%, the comparison fell just short of statistical significance (p=0.059). However, given the difference in the observed FIT adherence rate in the study from the projected one, demonstrating an adherence to Epi proColon® equaling the FIT adherence rate plus a margin of 3.2% would have been sufficient to prove superiority. In this scenario, the observed difference in adherence (11.4%) met statistical significance (p<0.0001). The ADMIT trial was requested by the FDA in the context of Epigenomics' PMA application for Epi proColon®. The study was originally designed to investigate CRC screening participation for average risk, screening eligible study subjects that were historically non-compliant to offered guideline-recommended screening methods (colonoscopy or FIT testing) and included 413 eligible subjects identified by Epigenomics' clinical trial partners, Kaiser Permanente and Geisinger Health Systems. Study subjects were randomized to either a FIT test kit for home use or a blood draw for the Epi proColon® test. Rates of adherence were compared between those that accepted and completed the blood test and those that accepted and completed the FIT test. An observational secondary objective of the study aims to demonstrate the number of patients who completed colonoscopy after positive test results with Epi proColon® or FIT. This data will be reported to the FDA once the study is formally completed within the next few weeks, i.e. up to six weeks after the last positive test result of a study subject was obtained.Further Information * On March 25, 2015, Epigenomics, announced the completion of subject enrollment into its ADMIT trial (ADherence to Minimally Invasive Testing - NCT02251782) for its non-invasive blood-based test for colorectal cancer (CRC) screening, Epi proColon®. The Company expects to announce results from this study during the second quarter of 2015. Study subjects were identified as historically non-compliant to CRC screening according to current screening guidelines by its partners, Kaiser Permanente and Geisinger Health Systems, who actively manage CRC screening programs in the U.S.A. Subjects were invited to a clinic visit and once enrolled into the trial, were randomized to either the FIT test to take home to complete and send back within six weeks, or to a blood draw for the Epi proColon® test, to be completed in the same time frame. Trial results will be submitted to the FDA following data analysis after completion of the six week response window. * On December 17, 2014, Epigenomics announced that first patients have been enrolled into its ADMIT trial (ADherence to Minimally Invasive Testing) for its noninvasive blood-based test for colorectal cancer (CRC) screening, Epi proColon®. The trial, which was requested by the FDA in the context of Epigenomics’ pre-market approval (PMA) application for Epi proColon®, will be conducted in 420 patients that have been historically non-compliant to CRC screening according to current screening guidelines. Epigenomics has partnered with two major U.S. health care systems, Kaiser Permanente and Geisinger Clinic, who actively manage CRC screening programs and who will identify the appropriate patients for the study within their managed patient populations. The trial aims to demonstrate that blood-based testing with Epi proColon® will increase compliance in CRC screening as compared to FIT stool-based testing. Patients will be invited to a clinic visit and once enrolled into the trial, they will be randomized to either the FIT test to take home to complete and send back or to a blood draw for completion of the Epi proColon® test. The primary endpoint aims to show a statistically significant increase in CRC screening participation by the patients in the trial as measured by the completion rate of either test. The study’s secondary objectives will comprise a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon® or FIT. Based on initial estimates, the company expects the trial to be enrolled within a few months.
