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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 : Recruiting
First Posted : September 26, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Salsabeel Ali Mahmoud, Cairo University

Tracking Information
First Submitted Date September 24, 2018
First Posted Date September 26, 2018
Last Update Posted Date July 23, 2019
Actual Study Start Date October 23, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03686020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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)
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)
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Egyptian population
Condition
  • Oral Potentially Malignant Lesions
  • Oral Cancer
Intervention Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)
Study Groups/Cohorts
  • Group I
    participants suffering from oral potentially malignant lesions
    Intervention: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
  • Group II
    participants suffering from diagnosed oral malignant lesions
    Intervention: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
  • Group III
    healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
    Intervention: Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 24, 2018)
24
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Salsabeel A Mahmoud 00201222343488 salsabeel_ali@hotmail.com
Contact: Basma A Zakaria basma.abdelalim@dentistry.cu.edu.eg
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03686020
Other Study ID Numbers 1152014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Salsabeel Ali Mahmoud, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date July 2019