Clinical trial · Observational
Quantitative Fecal Immunochemical Test for Detection of Colorectal Cancer and Precancerous Lesions in Sohag
Role of Quantitative Fecal Immunochemical Test as a Diagnostic Tool in Evaluation of Site and Type of Colorectal Cancer and Precancerous Lesions in Sohag Government
- 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)
Colorectal cancer is a major cause of cancer-related morbidity and mortality worldwide, and early detection significantly improves patient outcomes. The fecal immunochemical test (FIT) is a non-invasive stool-based test used for detection of colorectal cancer; however, its diagnostic performance varies according to lesion type and anatomical location. This prospective observational cohort study aims to evaluate the diagnostic accuracy of quantitative fecal immunochemical testing (qFIT) in detecting colorectal cancer and precancerous lesions, including advanced adenomas and sessile serrated lesions, in adults undergoing colonoscopy in Sohag Government. The study will assess the sensitivity, specificity, and optimal cutoff values of qFIT according to lesion type, location, and histopathological characteristics.
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 |
| Sessile Serrated Lesion | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Colorectal Cancer
- description
- Participants diagnosed with colorectal cancer confirmed by colonoscopy and histopathological examination.
- label
- Precancerous Lesions
- description
- Participants diagnosed with precancerous colorectal lesions, including advanced adenomas or sessile serrated lesions, confirmed by colonoscopy and histopathology.
- label
- Normal Colonoscopy
- description
- Participants with normal colonoscopy findings and no evidence of colorectal cancer or precancerous lesions.
Primary outcomes (1)
- measure
- Diagnostic Accuracy of Quantitative Fecal Immunochemical Test
- timeFrame
- Up to 1 day
- description
- Assessment of the diagnostic accuracy of quantitative fecal immunochemical testing (qFIT) for detection of colorectal cancer and precancerous colorectal lesions, expressed as sensitivity, specificity, positive predictive value, and negative predictive value, using colonoscopy and histopathology as the reference standard.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Adults aged 40 to 75 years * Individuals undergoing screening or diagnostic colonoscopy * Participants able to provide informed consent Exclusion Criteria: * Age below 40 years or above 75 years * History of colorectal surgery * Inflammatory bowel disease * Inadequate bowel preparation * Refusal to participate
References
Publications (0)
Data not yet available