Clinical trial · Interventional
Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit participants
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fecal Immunochemical Test | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FIT-DRE | Device | — | UNRESOLVED |
| FIT-SOC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FIT-SOC
- description
- Fecal immunochemical test performed on spontaneously passed stool as noted in the standard instructions.
- interventionNames
- Device: FIT-SOC
- type
- EXPERIMENTAL
- label
- FIT-DRE
- description
- Fecal immunochemical test completed with stool collected during digital rectal exam.
- interventionNames
- Device: FIT-DRE
Primary outcomes (1)
- measure
- Concordance between standard FIT results and DRE FIT results.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with a diagnosis of Inflammatory Bowel Disease (IBD). * Patients who are pregnant.
References
Publications (2)
- BACKGROUNDLee 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. PMID 24658694
- BACKGROUNDBrenner 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. PMID 23706981