Condition: Oral Leukoplakia · Oral Leukoplakia of Tongue · Oral Leukoplakia of Gingiva · Sponsor: University of Erlangen-Nürnberg Medical School
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 is to investigate MAGE-A as a predictive marker for the malignant transformation of OLP in the setting of a prospective, multicenter study and to establish it as a diagnostic parameter in addition to classical histology. In addition, the association of MAGE-A expression with the occurrence of immunological changes in OLP will be investigated in order to evaluate the possibility of minimally invasive immunotherapy of OLP. The study is intended to include 500 biopsies of non-selected patients with OLP from university institutions and private practices. The follow-up should be at least 3 years, w…
This description comes directly from the study's public registry record.
Manuel Weber, MD, DMD · 0049 9131 85 43749 · manuel.weber@uk-erlangen.de
Falk Wehrhan, MD, DMD · 0049 9131 85 43731 · falk.wehrhan@uk-erlangen.de
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| Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg | Erlangen, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT03975322