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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03686020

Acronym

CYFRA21-1

Enrollment

Registered

2018-09-26

Start date

2018-10-23

Completion date

2019-12-31

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer, Oral Potentially Malignant Lesions

Keywords

Oral potentially malignant lesions, Oral cancer, salivary CYFRA21-1, serum CYFRA21-1

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.

Interventions

DIAGNOSTIC_TESTEnzyme Linked Immunosorbent assay (ELISA)

measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactSalsabeel A Mahmoud

salsabeel_ali@hotmail.com00201222343488

Backup ContactBasma A Zakaria

basma.abdelalim@dentistry.cu.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026