UnknownNot Applicable

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

Egypt24 participantsStarted 2018-10-23

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer

Timeframe: one year

Trial details

NCT IDNCT03686020

SponsorCairo University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-10

Contact for this trial

Salsabeel A Mahmoud

00201222343488 salsabeel_ali@hotmail.com

View on ClinicalTrials.gov More Oral Potentially Malignant Lesions trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.