Clinical trial · Observational
Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer
Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study
- 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 the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.
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 Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The us-qFIT and colonoscopy with pathological examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Us-qFIT group
- description
- People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy.
- interventionNames
- Diagnostic Test: The us-qFIT and colonoscopy with pathological examination
Primary outcomes (1)
- measure
- The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
- timeFrame
- 24 months
- description
- The sensitivity, specificity, positive predictive value and negative predictive value.
Secondary outcomes (3)
- measure
- The accuracy of us-qFIT to diagnose colorectal cancer.
- timeFrame
- 24 months
- description
- The sensitivity, specificity, positive predictive value and negative predictive value.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 50-75 years old people; * People sign an "informed consent form" Exclusion Criteria: * People with history of colorectal surgery; * People with history of colorectal cancer; * People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract; * People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool; * People are in pregnancy, lactation or menstrual phase; * People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
References
Publications (0)
Data not yet available