Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Completed

• Conditions: Oral Cancer; Oral Premalignant Lesions as Leukoplakia and Lichen Planus
• Interventions: Diagnostic Test: serum and unstimulated salivary samples

• 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

Arm && Interventions

Group	Intervention	Description
Group I	serum and unstimulated salivary samples	patients suffering from oral squamous cell carcinoma
Group II	serum and unstimulated salivary samples	patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus
Group III	serum and unstimulated salivary samples	individuals with no oral mucosal lesions

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