Fecal Immunochemical Test Clinical Trial
Official title:
Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03209765 -
WhatsApp Reminder on FIT Compliance
|
N/A |