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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sohag University
- Enrollment
- 150
- Primary Endpoint
- Diagnostic Accuracy of Quantitative Fecal Immunochemical Test
Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Pierre Isac Ibrahim
Resident, Department of Internal Medicine, Faculty of Medicine, Sohag University
Sohag University