An observational study in Colorectal Cancer, sponsored by Epigenomics, Inc. Completed at 2 sites in United States. Open to participants aged 50 Years to 76 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-30.
Sponsored by Epigenomics, Inc · Observational
Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test) testing, both have patient-associated barriers that reduce their use. The combination of bowel preparation and procedure time are barriers to colonoscopy, while stool handling as part of the sampling protocol reduces FIT usage.
It has been hypothesized and supported by a variety of preference studies that the availability of a blood-based assay for CRC screening would increase patient participation and adherence to CRC screening by reducing barriers that prevent participation.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 490 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Epigenomics, Inc is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will encompass users of outpatient primary care clinics of one or more health care systems who are considered to be at average-risk for developing colorectal cancer (CRC), have not completed standard screening options, and are not up-to-date with a screening program. Such health care systems may include large healthcare networks with relatively stable patient bases such as Geisinger Health Systems (Danville, PA), Kaiser Permanente (Portland, OR).
Has not completed recommended screening for colonoscopy or FIT
Exclusion Criteria:
Subjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening.
Device: Epi proColon Test
Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening.
Device: Fecal Immunochemical Test (FIT)
For the purpose of comparison to usual care, participating health systems will build an anonymized group of patients meeting study eligibility criteria, who do not participate in the study. This group will serve as a passive control and their CRC screening activity will be monitored via Medical Record.
Subjects assigned to the Epi proColon arm will receive information on the Epi proColon test outlined in a template script. They will then be offered a blood draw for Epi proColon testing. The blood draw can be fulfilled at the clinic or at a specified blood draw station, at the convenience of the patient. Epi proColon plasma samples will be sent to a central laboratory for testing. If no test result is recorded within 4 weeks, patients will be mailed a reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
Subjects assigned to the FIT arm will receive information on the FIT test outlined in a template script. They will then be provided a FIT kit to take home and asked to send a stool sample to the testing lab following the kit instructions. If no test result is recorded within 4 weeks, subjects will receive a mailed reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
Comparison of Adherence to Screening for Each Group
* FIT Test Adherence: Adherence to the FIT Test is expressed as a percentage which is calculated as the number of subjects who complete stool testing within 42 days (6 weeks) divided by the total number of subjects enrolled in the FIT study arm. * Epi proColon Test Adherence: Adherence to Epi proColon is expressed as a percentage which is calculated as the number of subjects with documented blood draw for the Epi proColon Test within 42 days (6 weeks) divided by the total number of subjects enrolled in the Epi proColon Test arm. * Usual Care Test Adherence: Expressed as a percentage which is calculated as the number of subjects in the Usual Care Group with documented CRC screening (FIT or Colonoscopy) during the duration of the study, divided by the total number of subjects in the usual care group
Time frame: 9 months
Adherence to follow-up colonoscopy for tests with a positive result:
Documentation of colonoscopy completed within 42 days (6 weeks) after notification of positive test result
Time frame: 9 months
Diagnostic yield of colonoscopy:
Documentation of colonoscopy findings.
Time frame: 9 months
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Epigenomics, Inc