Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
490 participants
OBSERVATIONAL
2014-10-31
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Epi proColon Group
Subjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening.
Epi proColon Test
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.
FIT Group
Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening.
Fecal Immunochemical Test (FIT)
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.
Usual Care Group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epi proColon Test
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.
Fecal Immunochemical Test (FIT)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has not completed recommended screening for colonoscopy or FIT
* No colonoscopy in previous 10 years
* No fecal occult blood test (FOBT) or FIT in previous year and/or \> 13 months late FIT
* No flexible sigmoidoscopy in previous 5 years
* Verifiable offer of screening recommendation according to health system standard in at least two independent interactions and a verifiable lack of adherence for two most recent
* Verifiable lack of adherence for \>3 months following last screening recommendation
* Primary Care Provider (PCP) has agreed to refer patients for consideration of enrollment in the study
* Subject able to understand and sign written informed consent (IC)
Exclusion Criteria
* Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
* Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain)
* Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years)
* Chronic gastritis, pregnancy, cancer(s) other than colorectal
50 Years
76 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Epigenomics, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Theo deVos, Ph.D.
Role: STUDY_DIRECTOR
Director Development & Commercial Operations
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Epigenomics Homepage
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPR 0026
Identifier Type: -
Identifier Source: org_study_id