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Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore

NCT03975322 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-12-03

No results posted yet for this study

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.

Conditions

  • Oral Leukoplakia
  • Oral Leukoplakia of Tongue
  • Oral Leukoplakia of Gingiva
  • Oral Lichen Planus

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Manuel Weber, MD, DMD · Maxillofacial Surgery Erlangen

  • Falk Wehrhan, MD, DMD · Maxillofacial Surgery Erlangen

  • Jutta Ries, PhD · Maxillofacial Surgery Erlangen

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-12-30
Completion
2026-12-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975322 on ClinicalTrials.gov