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Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore

Recruitingn/aAges 18 Years - 80 YearsAllUniversity of Erlangen-Nürnberg Medical School
NCT03975322 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Early detection and prevention of OSCC is thought to have the highest potential to reduce morbidity and mortality. In prevention, the main focus is on precancerous lesions, especially oral leukoplakia (OLP), as up to 67% of OSCC arise on the basis of OLP. The determination of the transformation risk of OLP by histological determination of the degree of dysplasia is unreliable. A promising marker for the timely development of a OSCC is the detection of antigens of the MAGE-A gene family. The special feature of MAGE-A is that they can be detected in 93% of all OSCC and in approx. 85% of OLP that transform to OSCC. The detection of MAGE-A could also indicate changes in the immunological environment that occur prior to malignant OLP transformation and could be used for immunotherapies. Aim of this study i

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults, consenting male or female patients * Age 18 - 80 years * Diagnosis of one or more leukoplakia of the oral cavity including * leukoplakia associated wit lichen planus OR * leukoplakia associated with diseases of the immune system or immunosuppression OR * leukoplakia associated with a malignoma of other sites (except oral cavity) in the anamnesis * Existing consent to participation in the study after clarification has been given Exclusion Criteria: * clinical evidence of invasive carcinoma of the oral cavity OR * carcinoma of the oral cavity in the anamnesis OR * patients unable to give informed consent OR * rejection of the patient
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What it tests

  • Not listed
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Where

1 site
Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg
Erlangen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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