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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) (CYFRA21-1)

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ClinicalTrials.gov Identifier: NCT03686020
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Salsabeel Ali Mahmoud, 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.

Condition or disease Intervention/treatment
Oral Potentially Malignant Lesions Oral Cancer Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)

Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Oral Cancer

Group/Cohort Intervention/treatment
Group I
participants suffering from oral potentially malignant lesions
Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)

Group II
participants suffering from diagnosed oral malignant lesions
Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)

Group III
healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)




Primary Outcome Measures :
  1. sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Egyptian population
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686020


Contacts
Contact: Salsabeel A Mahmoud 00201222343488 salsabeel_ali@hotmail.com
Contact: Basma A Zakaria basma.abdelalim@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

Publications:

Responsible Party: Salsabeel Ali Mahmoud, PHD postgraduate student, Cairo University
ClinicalTrials.gov Identifier: NCT03686020     History of Changes
Other Study ID Numbers: 1152014
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salsabeel Ali Mahmoud, Cairo University:
Oral potentially malignant lesions
Oral cancer
salivary CYFRA21-1
serum CYFRA21-1

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases