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Search / Trial NCT03975322

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

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Jun 4, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Olp Oral Cancer Oscc Oral Squamous Cell Carcinoma

ClinConnect Summary

This clinical trial is studying a new way to predict whether a type of oral condition called oral leukoplakia (which can be a precancerous lesion) will turn into oral squamous cell carcinoma (OSCC), a common form of mouth cancer. Researchers are focusing on a specific marker called MAGE-A, which is found in many cases of OSCC and in a significant number of oral leukoplakia cases that become cancerous. By looking for this marker, the study aims to improve early detection and potentially guide treatment options, including immunotherapy, which helps the immune system fight cancer.

To participate in this study, individuals must be adults between the ages of 18 and 80 who have been diagnosed with oral leukoplakia. Participants will provide biopsies (small tissue samples), and their condition will be monitored for at least three years to see if cancer develops. The study is currently recruiting participants, and anyone interested in taking part will need to provide consent after understanding the details of the trial. This research could lead to better diagnostic tools and treatment options for people with oral leukoplakia.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About University Of Erlangen Nürnberg Medical School

The University of Erlangen-Nürnberg Medical School is a prestigious institution dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. Renowned for its interdisciplinary approach, the medical school fosters collaboration among experts in various fields, enabling the development of cutting-edge therapies and treatment protocols. With a commitment to ethical standards and patient safety, the institution actively contributes to the global medical community by conducting rigorous clinical studies aimed at enhancing the understanding and management of diverse health conditions.

Locations

Erlangen, , Germany

Patients applied

0 patients applied

Trial Officials

Manuel Weber, MD, DMD

Study Chair

Maxillofacial Surgery Erlangen

Falk Wehrhan, MD, DMD

Study Chair

Maxillofacial Surgery Erlangen

Jutta Ries, PhD

Study Chair

Maxillofacial Surgery Erlangen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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