Clinical trial · Observational
Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
NCT05232721CI-TRIAL-00056448unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The new instrument and colonoscopy with pathological examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fecal Immunochemical Test
- description
- People in this group will detect hemoglobin in stool before colonoscopy by the new instrument
- interventionNames
- Diagnostic Test: The new instrument and colonoscopy with pathological examination
Primary outcomes (1)
- measure
- Diagnostic performance of advanced neoplasms
- timeFrame
- 4 months
- description
- The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument
Secondary outcomes (1)
- measure
- Diagnostic performance of Colorectal Cancer
- timeFrame
- 4 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * People who use the new instrument for fecal immunochemical test(FIT) * People sign an "informed consent form" Exclusion Criteria: * People with history of surgery in any part of the large bowel; * People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);
References
Publications (0)
Data not yet available
No reference posted for this study.