Quantitative Fecal Immunochemical Test for Detection of Colorectal Cancer and Precancerous Lesions in Sohag
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Colorectal Adenoma, Sessile Serrated Lesion. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Primary outcome measures
- Diagnostic Accuracy of Quantitative Fecal Immunochemical Test [Time frame: Up to 1 day]
Secondary outcome measures (3)
- Diagnostic Performance of qFIT by Lesion Type [Time frame: Up to 1 day]
- Diagnostic Performance of qFIT by Lesion Location [Time frame: Up to 1 day]
- Correlation Between qFIT Level and Lesion Characteristics [Time frame: Up to 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07410546 · Soh-Med--25-11-17MS