Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions

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.

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Key information

Conditions

Oral Premalignant Lesions as Leukoplakia and Lichen Planus Head and Neck Neoplasms Lichen Planus Lichenoid Eruptions Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum and unstimulated salivary samples

Diagnostic Test

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

Primary outcomes

DPP-4 level detection

Time frame: 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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Oct 17, 2023
Registry last updated: Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed