Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Completed

• Conditions: Oral Cancer; Oral Premalignant Lesions as Leukoplakia and Lichen Planus

• Registration Number: NCT06087042
• Lead Sponsor: Fayoum University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-16
• Last Update Submitted: 2023-10-16
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• systemically healthy
• No current medication,
• both genders with age ranging from 30 to 65 years old.
• having oral leukoplakia, oral lichen planus or oral squamous cell carcinoma

Exclusion Criteria

• systemic disease
• pregnancy
• lactation
• being diagnosed with any other oral mucosal lesion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DPP-4 level detection	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	level of DPP-4 is measured in all collected serum and salivary samples

Trial Locations

Locations (1)

faculty of dentistry, Fayoum university; 🇪🇬 Fayoum, Egypt