An observational study in Oral Premalignant Lesions as Leukoplakia and Lichen Planus and Oral Cancer, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by Fayoum University · Observational
Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in carcinogenesis.
Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15 patients having oral squamous cell carcinoma. Group II: 15 patients with potentially malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy participants having no oral mucosal lesions acting as a control group (Group III). Serum and whole unstimulated salivary samples were collected from all participants to evaluate dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity and diagnostic accuracy of DPP-4 among different groups.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's enrollment of 45 is below the median of 80 across 17 observational studies indexed under Lichen Planus.
Browse Lichen Planus studies →Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
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adult individuals entering in the out patient clinics of oral medicine and diagnosis department
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Exclusion Criteria:
patients suffering from oral squamous cell carcinoma
Diagnostic Test: serum and unstimulated salivary samples
patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus
Diagnostic Test: serum and unstimulated salivary samples
individuals with no oral mucosal lesions
Diagnostic Test: serum and unstimulated salivary samples
Participants were told to cease smoking, eating, or drinking before the collection of samples by about half an hour. Obtaining the sample was done by demanding the individual to swallow then incline his head forward to expectorate saliva in a sterile tube for about 3 min. Afterwards the samples were coded by serial numbers then stored at -20°C until being assessed. Under aseptic circumstances and using plain tubes, 5ml peripheral venous blood samples were collected from all participants by standard venipuncture. Samples were transported to biochemistry laboratory and centrifuged followed by filtration of the clarifying supernatant and then stored at -20ºC
DPP-4 level detection
level of DPP-4 is measured in all collected serum and salivary samples
Time frame: level of DPP-4 is measured after the completion of all sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Plan to share: No
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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