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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Colorectal Adenoma; Sessile Serrated Lesion

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Pierre Isac Ibrahim; Phone Number: +201273119744; Email: bebareshak@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult participants undergoing screening or diagnostic colonoscopy at Sohag University Hospital, including individuals with colorectal cancer, precancerous lesions, or normal colonoscopy findings.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Colorectal Cancer; Participants diagnosed with colorectal cancer confirmed by colonoscopy and histopathological examination.
Precancerous Lesions; Participants diagnosed with precancerous colorectal lesions, including advanced adenomas or sessile serrated lesions, confirmed by colonoscopy and histopathology.
Normal Colonoscopy; Participants with normal colonoscopy findings and no evidence of colorectal cancer or precancerous lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of Quantitative Fecal Immunochemical Test	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.	Up to 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance of qFIT by Lesion Type	Comparison of quantitative fecal immunochemical test performance for detection of colorectal cancer, advanced adenomas, and sessile serrated lesions.	Up to 1 day
Diagnostic Performance of qFIT by Lesion Location	Evaluation of quantitative fecal immunochemical test performance according to anatomical location of colorectal lesions, including proximal colon, distal colon, and rectum.	Up to 1 day
Correlation Between qFIT Level and Lesion Characteristics	Assessment of the relationship between fecal hemoglobin concentration and lesion size, morphology, and histopathological grade.	Up to 1 day

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Usama Abdelaal, MD, Faculty of Medicine, Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 7, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Soh-Med--25-11-17MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. The data are collected and analyzed for an academic thesis and will be reported in aggregate form only, with no plan for public or external data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No