Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Study Overview
=================
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.

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

Conditions
-----------------
Oral Premalignant Lesions as Leukoplakia and Lichen Planus, Oral Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: serum and unstimulated salivary samples


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>patients suffering from oral squamous cell carcinoma | Diagnostic Test: serum and unstimulated salivary samples<br>* 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<br>|
| Group II<br>patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus | Diagnostic Test: serum and unstimulated salivary samples<br>* 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<br>|
| Group III<br>individuals with no oral mucosal lesions | Diagnostic Test: serum and unstimulated salivary samples<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral cancer, saliva, serum, dipeptidyl peptidase, potentially malignant lesions.