NCT03975322 Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
| NCT ID | NCT03975322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Oral Leukoplakia |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2019-12-01 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2019-12-01 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, whereby it is examined whether an OSCC on the basis of the original OLP developed. After three years, an interim evaluation of the results with statistical evaluation will be carried out. In order to ensure that the course of the disease is monitored for at least three years for all OLPs, an extension of the monitoring period to 5 years is planned. The study could establish a routine diagnostic parameter to supplement the histo-morphological diagnosis of OLP and evaluate the possibility of immunotherapy of OLP.
Eligibility Criteria
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
Contact & Investigator
Manuel Weber, MD, DMD
STUDY CHAIR
Maxillofacial Surgery Erlangen
Frequently Asked Questions
Who can join the NCT03975322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Oral Leukoplakia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03975322 currently recruiting?
Yes, NCT03975322 is actively recruiting participants. Contact the research team at manuel.weber@uk-erlangen.de for enrollment information.
Where is the NCT03975322 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT03975322 clinical trial?
NCT03975322 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Manuel Weber, MD, DMD at Maxillofacial Surgery Erlangen. The trial plans to enroll 500 participants.