Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Oral Cancer Clinical Trial

Official title:

Association of Serum and Salivary Dipeptidyl Peptidase-4 (DPP-4) With Oral Cancerous and Precancerous Lesions; an Observational Diagnostic Accuracy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06087042
• Other study ID #: : IRB00012891#77
• Status: Completed
• Start date: August 15, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukoplakia
• Lichen Planus
• Mouth Neoplasms
• Oral Cancer
• Precancerous Conditions

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of dentistry, Fayoum university	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DPP-4 level detection	level of DPP-4 is measured in all collected serum and salivary samples	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