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NCT Number: NCT07410546

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic Accuracy of Quantitative Fecal Immunochemical Test

    Time frame: Up to 1 day

    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.

Secondary outcomes

  1. Diagnostic Performance of qFIT by Lesion Type

    Time frame: Up to 1 day

    Comparison of quantitative fecal immunochemical test performance for detection of colorectal cancer, advanced adenomas, and sessile serrated lesions.

  2. Diagnostic Performance of qFIT by Lesion Location

    Time frame: Up to 1 day

    Evaluation of quantitative fecal immunochemical test performance according to anatomical location of colorectal lesions, including proximal colon, distal colon, and rectum.

  3. Correlation Between qFIT Level and Lesion Characteristics

    Time frame: Up to 1 day

    Assessment of the relationship between fecal hemoglobin concentration and lesion size, morphology, and histopathological grade.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Isac Ibrahim

CONTACT

[email protected]

+201273119744

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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