Actively Recruiting
Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
Led by University of Erlangen-Nürnberg Medical School · Updated on 2019-12-03
500
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Male or female patients who consent to participate
- Diagnosis of one or more oral leukoplakia lesions
- Leukoplakia linked with lichen planus or immune system diseases
- Leukoplakia with history of malignancy at other sites (excluding oral cavity)
- Provided informed consent to join the study
You will not qualify if you...
- Clinical signs of invasive oral cavity cancer
- History of oral cavity carcinoma
- Unable to give informed consent
- Declined participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg
Erlangen, Germany, 91054
Actively Recruiting
Research Team
M
Manuel Weber, MD, DMD
CONTACT
F
Falk Wehrhan, MD, DMD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here