Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)

Study Overview
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Brief Summary
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The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.

Official Title
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Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)

Conditions
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Oral Potentially Malignant Lesions, Oral Cancer

Intervention / Treatment
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* Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants will be divided into 3 groups: Group I: patients suffering from oral potentially malignant lesions (PML) as defined by World Health Organization. Group II: patients suffering from diagnosed oral malignant lesions Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions. Exclusion Criteria: Subjects taking any drugs inducing any changes that could affect the salivary flow. Pregnant females. Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling. Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>participants suffering from oral potentially malignant lesions | Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)<br>* measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)<br>|
| Group II<br>participants suffering from diagnosed oral malignant lesions | Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)<br>* measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)<br>|
| Group III<br>healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions. | Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)<br>* measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer | diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral potentially malignant lesions, Oral cancer, salivary CYFRA21-1, serum CYFRA21-1