Quantitative Fecal Immunochemical Test for Detection of Colorectal Cancer and Precancerous Lesions in Sohag
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSohag University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 40 to 75 years
Individuals undergoing screening or diagnostic colonoscopy
Participants able to provide informed consent
Disqualifiers
Age below 40 years or above 75 years
History of colorectal surgery
Inflammatory bowel disease
Inadequate bowel preparation
Trial population
Adult participants undergoing screening or diagnostic colonoscopy at Sohag University Hospital, including individuals with colorectal cancer, precancerous lesions, or normal colonoscopy findings.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: Colorectal Cancer
Group B: Precancerous Lesions
Group C: Normal Colonoscopy
Trial outcomes
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.
Time frame
Up to 1 daySecondary outcomes
1
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.
Time frame
Up to 1 day2
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.
Time frame
Up to 1 day3
Correlation Between qFIT Level and Lesion Characteristics
Assessment of the relationship between fecal hemoglobin concentration and lesion size, morphology, and histopathological grade.
Time frame
Up to 1 dayLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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