Fecal Immunochemical TestPhase 1FIT-DRENCT03013855
Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam
A Phase 1 study testing FIT-SOC and FIT-DRE in people with Fecal Immunochemical Test, run by Boston Medical Center at 1 site in United States.
Trial summary
This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Immunochemical Test
- What is being tested?
- FIT-SOC and FIT-DRE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between the ages of 50-75 who are due for colon cancer screening and scheduled for colonoscopy
- Preoperative patients with established diagnosis of colon cancer
Who cannot join
- Patients with a diagnosis of Inflammatory Bowel Disease (IBD).
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition, some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE. This study aims to assess the correlation between FIT using the stool sample from DRE (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help avoid logistical barriers, as well as improve compliance and adherence to colon cancer screening in the outpatient setting, eventually leading to improved quality of care.
Read the detailed description
Fecal immunochemical testing (FIT) is an FDA-approved stool-based screening test for colorectal cancer. It offers a less invasive colorectal cancer screening option for patients who are not agreeable to colonoscopy and measures the level of Ab-globin complexes in the stool without direct interference with diet or medications. FIT has been shown to be selective for colorectal bleeding, as globin from the upper GI tract is digested by proteolytic enzymes. A meta-analysis of studies analyzing FIT showed a pooled sensitivity of 0.79 (95% CI 0.69-0.86) and specificity was 0.94 (CI 0.92-0.95). In a large study comparing FIT with another stool-based screening test, gFOBT, sensitivity of FIT was found to be 0.53-0.73 for CRC and 0.20-0.25 for advanced neoplasia compared to gFOBT, which showed 33.3% for CRC and 8.6% for advanced neoplasia. In addition, FIT requires fewer stool samples and the lack of dietary or medication modifications. As a result, compliance is likely to be higher, which is crucial for cancer detection.
A challenge inherent to stool-based screening tests is compliance with sample submission by the patients. FIT is meant to improve logistical barriers to screening because only one sample is needed, however, compliance rates with standard of care FIT (FIT-SOC) is approximately 50%. FIT using stool from a digital rectal exam (DRE) performed during a clinic visit may be an effective screening tool for patients preferring stool-based screening. FIT has been FDA-approved for the testing of spontaneously passed stool, as well as stool collected by DRE. Manufacturers of FIT have claimed that DRE provides a sufficient amount of stool for sampling, however, there are no validated studies to our knowledge which demonstrate adequate efficacy. As a result, FIT using DRE is not commonly done in clinical practice. This study aims to assess the correlation of FIT using DRE (FIT-DRE) with standard of care FIT (FIT-SOC) as a method of obtaining stool samples.
- Conditions
- Fecal Immunochemical Test
- Being tested
- FIT-SOC, FIT-DRE
- Keywords
- Digital rectal exam, Colon cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT-SOCDevice
Study subjects will be given a standard kit for fecal immunochemical test by their primary healthcare provider. As per standard practice, the patient will take the kit home and use the included FIT applicator to collect a stool sample from spontaneously passed stool during a regular bowel movement. The patient will then mail the stool sample to the lab in a pre-paid envelope, which is provided in the kit.
FIT-DREDevice
Study subjects will have a digital rectal exam completed by their primary care providers during the physical exam portion of a routine clinic visit. The stool collected on the examiner's finger will be applied to the FIT applicator in the standard kit, which will then be sent to the lab for processing.
| Study group | Role | What they receive |
|---|---|---|
| FIT-SOC | Active comparator | Fecal immunochemical test performed on spontaneously passed stool as noted in the standard instructions. Receives: Device: FIT-SOC |
| FIT-DRE | Experimental | Fecal immunochemical test completed with stool collected during digital rectal exam. Receives: Device: FIT-DRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between standard FIT results and DRE FIT results.
For example, the percentage of positive standard FIT results that also have positive DRE FIT results, and the percentage of negative standard FIT results that also have negative DRE FIT results.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fecal Immunochemical TestStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Jacobson, MD, Study director, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013855
- Sponsor's protocol ID
- H-34258
- Acronym
- FIT-DRE
- Status last verified
- Jul 2017
- First submitted
- 17 Aug 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.
PubMed 24658694Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer. 2013 Sep;49(14):3049-54. doi: 10.1016/j.ejca.2013.04.023. Epub 2013 May 22.
PubMed 23706981
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam
- ClinicalTrials.gov ID
- NCT03013855
- Acronym / sponsor ID
- FIT-DRE / H-34258
- Conditions
- Fecal Immunochemical Test
- Keywords
- Digital rectal exam, Colon cancer screening
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Jan 2017 (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.
This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition, some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE. This study aims to assess the correlation between FIT using the stool sample from DRE (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help avoid logistical barriers, as well as improve compliance and adherence to colon cancer screening in the outpatient setting, eventually leading to improved quality of care.
Detailed description
Fecal immunochemical testing (FIT) is an FDA-approved stool-based screening test for colorectal cancer. It offers a less invasive colorectal cancer screening option for patients who are not agreeable to colonoscopy and measures the level of Ab-globin complexes in the stool without direct interference with diet or medications. FIT has been shown to be selective for colorectal bleeding, as globin from the upper GI tract is digested by proteolytic enzymes. A meta-analysis of studies analyzing FIT showed a pooled sensitivity of 0.79 (95% CI 0.69-0.86) and specificity was 0.94 (CI 0.92-0.95). In a large study comparing FIT with another stool-based screening test, gFOBT, sensitivity of FIT was found to be 0.53-0.73 for CRC and 0.20-0.25 for advanced neoplasia compared to gFOBT, which showed 33.3% for CRC and 8.6% for advanced neoplasia. In addition, FIT requires fewer stool samples and the lack of dietary or medication modifications. As a result, compliance is likely to be higher, which is crucial for cancer detection.
A challenge inherent to stool-based screening tests is compliance with sample submission by the patients. FIT is meant to improve logistical barriers to screening because only one sample is needed, however, compliance rates with standard of care FIT (FIT-SOC) is approximately 50%. FIT using stool from a digital rectal exam (DRE) performed during a clinic visit may be an effective screening tool for patients preferring stool-based screening. FIT has been FDA-approved for the testing of spontaneously passed stool, as well as stool collected by DRE. Manufacturers of FIT have claimed that DRE provides a sufficient amount of stool for sampling, however, there are no validated studies to our knowledge which demonstrate adequate efficacy. As a result, FIT using DRE is not commonly done in clinical practice. This study aims to assess the correlation of FIT using DRE (FIT-DRE) with standard of care FIT (FIT-SOC) as a method of obtaining stool samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT-SOC | Active comparator | Device: FIT-SOCFecal immunochemical test performed on spontaneously passed stool as noted in the standard instructions. |
| FIT-DRE | Experimental | Device: FIT-DREFecal immunochemical test completed with stool collected during digital rectal exam. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults between the ages of 50-75 who are due for colon cancer screening and scheduled for colonoscopy
- Preoperative patients with established diagnosis of colon cancer
Key exclusion criteria (2 listed)
- Patients with a diagnosis of Inflammatory Bowel Disease (IBD).
- Patients who are pregnant.
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 |
|---|---|---|
| FIT-SOCStudy subjects will be given a standard kit for fecal immunochemical test by their primary healthcare provider. As per standard practice, the patient will take the kit home and use the included FIT applicator to collect a stool sample from spontaneously passed stool during a regular bowel movement. The patient will then mail the stool sample to the lab in a pre-paid envelope, which is provided in the kit. | Device | FIT-SOC |
| FIT-DREStudy subjects will have a digital rectal exam completed by their primary care providers during the physical exam portion of a routine clinic visit. The stool collected on the examiner's finger will be applied to the FIT applicator in the standard kit, which will then be sent to the lab for processing. | Device | FIT-DRE |
Primary outcome
Concordance between standard FIT results and DRE FIT results.
Time frame: 1 year
For example, the percentage of positive standard FIT results that also have positive DRE FIT results, and the percentage of negative standard FIT results that also have negative DRE FIT results.
Results and safety
The study was stopped early (reason given: Unable to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Background: PubMed 24658694Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.
- Background: PubMed 23706981Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer. 2013 Sep;49(14):3049-54. doi: 10.1016/j.ejca.2013.04.023. Epub 2013 May 22.
- Individual participant dataSharing planned: Undecided
Related trials for Fecal Immunochemical Test
Active, not recruiting
The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Colorectal Cancer
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Recruiting
Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
Colorectal Polyp, Colorectal Neoplasms
Recruiting
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Adenoma Detection Rate, Colonoscopy
RecruitingPhase 3
EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO)
Colorectal Cancer Screening
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.
Brian Jacobson, MD study director
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FIT-SOC and FIT-DRE in people with Fecal Immunochemical Test, run by Boston Medical Center at 1 site 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit participants). Results are not available in the source record.
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?
Concordance between standard FIT results and DRE FIT results. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013855, which also lists 2 linked publications.
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 31 Jul 2017.