NCT07410546

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a prospective observational cohort study conducted at a tertiary care endoscopy unit in Sohag Government. Adult patients aged 40 to 75 years who are referred for diagnostic or screening colonoscopy will be invited to participate. All eligible participants will provide a stool sample for quantitative fecal immunochemical testing (qFIT) prior to bowel preparation. Fecal hemoglobin concentration will be measured using a quantitative FIT assay and expressed as micrograms of hemoglobin per gram of stool. All participants will subsequently undergo colonoscopy as part of routine clinical care. Colonoscopic findings will be recorded, including lesion presence, anatomical location (proximal colon, distal colon, or rectum), size, and morphology. Biopsy or polypectomy specimens will be examined histopathologically to confirm colorectal cancer, advanced adenomas, or sessile serrated lesions. The diagnostic performance of qFIT will be evaluated by calculating sensitivity, specificity, positive predictive value, and negative predictive value for detection of colorectal cancer and precancerous lesions. Receiver operating characteristic (ROC) curve analysis will be used to determine optimal qFIT cutoff values according to lesion type and anatomical location. Associations between qFIT levels and lesion characteristics will also be analyzed.

Conditions

• Colorectal Cancer
• Colorectal Adenoma
• Sessile Serrated Lesion

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-02-13
• Last updated: 2026-02-13