Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway
NCT07237984
Colonic Diseases, Colorectal Adenoma
Hillerød, Denmark
View Trial DetailsNCT Number: NCT07410546
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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Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 1 day
Comparison of quantitative fecal immunochemical test performance for detection of colorectal cancer, advanced adenomas, and sessile serrated lesions.
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.
Time frame: Up to 1 day
Assessment of the relationship between fecal hemoglobin concentration and lesion size, morphology, and histopathological grade.
Contact information is provided by the study sponsor or research team.
Sohag University
Other
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
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