Testing a MAGE-A marker to predict cancer risk in oral leukoplakia
Studies whether a MAGE-A marker in biopsies predicts oral leukoplakia turning into mouth cancer.
Plain-language title generated from the registry record
Registry title: Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
Key facts
- Where
- Erlangen, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who have one or more white patches (leukoplakia) in the mouth and agree to take part.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- One or more leukoplakia lesions in the mouth. This includes leukoplakia linked to lichen planus, to immune system disease or immunosuppression, or to a cancer elsewhere in the past.
Main reasons for not taking part
- Signs of invasive cancer in the mouth
- Mouth cancer in the past
- Unable to give informed consent
- Patient refuses to take part
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT03975322, who can take part
Where in Germany
- Universitätsklinikum Erlangen, FAU Erlangen-NürnbergErlangen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Erlangen-Nürnberg Medical School
- Trial code
- NCT03975322
- Record updated
- 3 December 2019
- Original description
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.Read full original descriptionShow less
Prospective Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
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.
Inclusion: 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: 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.