Adherence to Minimally Invasive Testing (ADMIT)

Epigenomics

Status: Completed

Conditions: Colorectal Cancer

Treatments: Device: Epi proColon Test; Device: Fecal Immunochemical Test (FIT)

Study type: Observational

Funder types: Industry

Identifiers

NCT02251782

SPR 0026

Details and patient eligibility

About

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.

Enrollment: 490 patients

Sex: All

Ages: 50 to 76 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 50 years of age or greater, but less than 76 years old

• 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

• Family history of CRC in a first-degree relative
• 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

Trial design

490 participants in 3 patient groups

Epi proColon Group

Description:

Subjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening.

Treatment:

Device: Epi proColon Test

FIT Group

Description:

Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening.

Treatment:

Device: Fecal Immunochemical Test (FIT)

Usual Care Group

Description:

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.