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: Oral Potentially Malignant Lesions; Oral Cancer
• Interventions: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)

• Registration Number: NCT03686020
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Study Start: 2018-10-23
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	Enzyme Linked Immunosorbent assay (ELISA)	participants suffering from oral potentially malignant lesions
Group III	Enzyme Linked Immunosorbent assay (ELISA)	healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
Group II	Enzyme Linked Immunosorbent assay (ELISA)	participants suffering from diagnosed oral malignant lesions

Primary Outcome Measures

Name	Time	Method
sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer	one year	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt