Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer; Oral Premalignant Lesions as Leukoplakia and Lichen Planus
• Intervention / Treatment: Diagnostic test: serum and unstimulated salivary samples

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • faculty of dentistry, Fayoum university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

adult individuals entering in the out patient clinics of oral medicine and diagnosis department

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; patients suffering from oral squamous cell carcinoma	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
Group II; patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus	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
Group III; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Principal Investigator: Nayroz Tarrad, associate professor, faculty of dentistry, Fayoum university

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: oral cancer; saliva; serum; dipeptidyl peptidase; potentially malignant lesions.
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Precancerous Conditions; Mouth Neoplasms; Leukoplakia; Lichen Planus
• Other Study ID Numbers: : IRB00012891#77

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No