Actively Recruiting
Prospective 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Oral squamous cell carcinoma (OSCC) is a common cancer worldwide, often developing from oral leukoplakia (OLP), a precancerous lesion. This research aims to study the expression of MAGE-A antigens as a marker to predict the risk of OLP turning into OSCC. The study also explores the connection between MAGE-A expression and changes in the immune environment, which may lead to new immunotherapy options for OLP. The study is prospective and multicenter, focusing on improving early detection and treatment strategies for OLP to reduce OSCC morbidity and mortality. Participants diagnosed with OLP will undergo routine photo documentation and biopsy of the lesion. The biopsy tissue will be split: one part fixed for routine histology and the other preserved for molecular analysis of MAGE-A expression. The standard clinical treatment will be followed based on histological findings, with lesions showing higher risk treated surgically or by laser. The study includes a follow-up period of at least three years, with evaluations at two and three years, and plans to extend monitoring to five years to observe any malignant transformations. Participants will be monitored through clinical visits, with biopsy results and analyses performed at a central lab. The study tracks the presence of MAGE-A as a potential predictive marker alongside traditional histology. Researchers will assess how well MAGE-A predicts malignant transformation and study immune changes in lesions. The main outcome is measuring malignant transformation related to MAGE-A expression over two, three, and five years. This study may lead to new diagnostic and treatment methods for OLP patients.
CONDITIONS
Brief 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, consenting male or female patients
- Age 18 - 80 years
- Diagnosis of one or more leukoplakia of the oral cavity
- Leukoplakia associated with lichen planus or immune system diseases or immunosuppression
- Leukoplakia associated with a history of malignoma at other sites (except oral cavity)
- Existing consent to participate in the study after being informed
You will not qualify if you...
- Clinical evidence of invasive carcinoma of the oral cavity
- History of carcinoma of the oral cavity
- Patients unable to give informed consent
- Patient refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo photo documentation and incision biopsy of oral leukoplakia lesions following routine clinical diagnostic guidelines. Tissue samples are collected and sent for standard histological evaluation and additional molecular analyses.
1 visit (in-person)
Duration - Up to 5 years
Participants with low-risk lesions (D0 and D1) are monitored over time to observe for malignant transformation, while those with higher-risk lesions (D2 and D3) receive treatment as per standard care but remain in the study for observation. Follow-up evaluations occur to assess progression and outcomes.
Follow-up visits approximately every 6 months over 3 years with additional assessments up to 5 years
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg
Erlangen, Germany, 91054
Actively Recruiting
Research Team
M
Manuel Weber, MD, DMD
F
Falk Wehrhan, MD, DMD
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
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