Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT06087042

Collaborator

(none)

Enrollment

Location

1.5

Actual Duration (Months)

29.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Premalignant Lesions as Leukoplakia and Lichen Planus Oral Cancer	Diagnostic Test: serum and unstimulated salivary samples

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 15, 2023

Actual Primary Completion Date :

Oct 1, 2023

Actual Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	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

Arm

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

Group III

individuals with no oral mucosal lesions

Diagnostic Test: serum and unstimulated salivary samples

Outcome Measures

Primary Outcome Measures

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