Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adults, consenting male or female patients
Age 18 - 80 years
Diagnosis of one or more leukoplakia of the oral cavity
leukoplakia associated wit lichen planus OR
Disqualifiers
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
Trial population
Patients with clinically proven leukoplakia (OLP) of the oral cavity (whitish, non-wipeable oral mucosa changes that cannot be attributed to any disease) are to be included in the study.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Dependence of malignant transformation on a MAGE-A based immunoscore
Association of OLP malignant transformation with a MAGE-A based immunoscore. Into this score, the following immunohistochemical and molecular biological parameters determined in biopsies will be integrated: * MAGE-A expression * Macrophage infiltration and polarization (CD68, CD163) * T cell infiltration (CD3, CD8) * Altered expression of immune checkpoints and TLR receptors (PD-L1, PD-L2, TLR7) These parameters will be aggregated to an immunoscore
Time frame
2 years2
Dependence of malignant transformation on a MAGE-A based immunoscore
Association of OLP malignant transformation with a MAGE-A based immunoscore. Into this score, the following immunohistochemical and molecular biological parameters determined in biopsies will be integrated: * MAGE-A expression * Macrophage infiltration and polarization (CD68, CD163) * T cell infiltration (CD3, CD8) * Altered expression of immune checkpoints and TLR receptors (PD-L1, PD-L2, TLR7) These parameters will be aggregated to an immunoscore
Time frame
3 years3
Dependence of malignant transformation on a MAGE-A based immunoscore
Association of OLP malignant transformation with a MAGE-A based immunoscore. Into this score, the following immunohistochemical and molecular biological parameters determined in biopsies will be integrated: * MAGE-A expression * Macrophage infiltration and polarization (CD68, CD163) * T cell infiltration (CD3, CD8) * Altered expression of immune checkpoints and TLR receptors (PD-L1, PD-L2, TLR7) These parameters will be aggregated to an immunoscore
Time frame
5 yearsSecondary outcomes
1
Frequency of malignant transformation
Frequency of malignant transformation of OLP (determination of the incidence of OSCC in OLP cases)
Time frame
2 years2
Frequency of malignant transformation
Frequency of malignant transformation of OLP (determination of the incidence of OSCC in OLP cases)
Time frame
3 years3
Frequency of malignant transformation
Frequency of malignant transformation of OLP (determination of the incidence of OSCC in OLP cases)
Time frame
5 years4
Dependence of malignant transformation on dysplasia
Dependence of malignant transformation on histologically determined degree of dysplasia (D0-D3)
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov