Clinical trial · Observational
A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma
A New Quantitative Fecal Immunochemical Test Can Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma.
- 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. Because of the less bleeding of advanced adenomas, the sensitivity of existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared with existing commercially available qFIT, is developed and this study will prove the high diagnostic accuracy in detecting colorectal advanced adenoma.
Conditions
Conditions (3)
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 Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The new qFIT and colonoscopy with pathological examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Fecal Occult Blood Test
- description
- People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.
- interventionNames
- Diagnostic Test: The new qFIT and colonoscopy with pathological examination
Primary outcomes (1)
- measure
- The accuracy of the new qFIT to diagnose colorectal advanced adenoma.
- timeFrame
- 18 months
- description
- The sensitivity, specificity, positive predictive value and negative predictive value.
Secondary outcomes (2)
- measure
- The accuracy of the new qFIT to diagnose colorectal cancer.
- timeFrame
- 18 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 surgery in any part of the large bowel; * People with history of colorectal cancer; * People with history of other diseases that may produce fecal blood, such as active diverticulitis, inflammatory bowel disease, ischemic enteritis, vascular malformation 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 7th type stool (Bristol feces score); * 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