Quantitative Fecal Immunochemical Test for Detection of Colorectal Cancer and Precancerous Lesions in Sohag

NCT07410546 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med--25-11-17MS
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer; Colorectal Adenoma; Sessile Serrated Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic Performance of qFIT by Lesion Type

  Up to 1 day

• Diagnostic Performance of qFIT by Lesion Location

  Up to 1 day

• Correlation Between qFIT Level and Lesion Characteristics

  Up to 1 day

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged 40 to 75 years
• Individuals undergoing screening or diagnostic colonoscopy
• Participants able to provide informed consent

You may not qualify if:

• Age below 40 years or above 75 years
• History of colorectal surgery
• Inflammatory bowel disease
• Inadequate bowel preparation
• Refusal to participate

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Usama Abdelaal, MD

  Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Isac Ibrahim

CONTACT

+201273119744; bebareshak@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Internal Medicine, Faculty of Medicine, Sohag University

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share