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

Cairo University (CU)

Status

Unknown

Conditions

Oral Potentially Malignant Lesions

Oral Cancer

Treatments

Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)

Study type

Observational

Funder types

Other

Identifiers

NCT03686020

1152014

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.