Colorectal CancerADMITNCT02251782
Adherence to Minimally Invasive Testing
An observational study of Colorectal Cancer, run by Epigenomics, Inc at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Epi proColon Test and Fecal Immunochemical Test (FIT)
- Type of treatment
- Medical device
- How many people
- 490 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger Clinic
Danville, Pennsylvania, 17822
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Adherence to Minimally Invasive CRC Screening In Non-Adherent Patients Who Have Not Completed Colorectal Cancer Screening
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.
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Epi proColon Test, Fecal Immunochemical Test (FIT)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi proColon TestDevice
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Epi proColon Group | Subjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening. Receives: Device: Epi proColon Test | |
| FIT Group | Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening. Receives: Device: Fecal Immunochemical Test (FIT) | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (2)
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
Measured: 9 months
Diagnostic yield of colonoscopy:
Documentation of colonoscopy findings.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epigenomics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theo deVos, Ph.D., Study director, Director Development & Commercial Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251782
- Sponsor's protocol ID
- SPR 0026
- Acronym
- ADMIT
- Status last verified
- Jun 2015
- First submitted
- 24 Sep 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Minimally Invasive CRC Screening In Non-Adherent Patients Who Have Not Completed Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT02251782
- Acronym / sponsor ID
- ADMIT / SPR 0026
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Epigenomics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epi proColon Group | – | Device: Epi proColon TestSubjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening. |
| FIT Group | – | Device: Fecal Immunochemical Test (FIT)Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening. |
| 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. |
Who may qualify
- Ages
- 50 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (9 listed)
- 50 years of age or greater, but less than 76 years old
- Has not completed recommended screening for colonoscopy or 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epi proColon TestSubjects 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. | Device | Epi proColon Group |
| 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. | Device | FIT Group |
Primary outcome
Comparison of Adherence to Screening for Each Group
Time frame: 9 months
* 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
2 secondary outcomes
Adherence to follow-up colonoscopy for tests with a positive result:
Time frame: 9 months
Diagnostic yield of colonoscopy:
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Epigenomics HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theo deVos, Ph.D. study director
Director Development & Commercial Operations
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Epigenomics, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Adherence to Screening for Each Group (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.