Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Predicting cancer risk in oral leukoplakia using MAGE-A markers

Official title: Prospective Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore

Run by University of Erlangen-Nürnberg Medical School · NCT03975322 · Data updated 2026-11-12

This study is trying to see if certain markers in people with oral leukoplakia can help predict their risk of developing oral cancer.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment500 (estimated)
SponsorUniversity of Erlangen-Nürnberg Medical School
Academic / other
Drugs / interventionsimmunotherapy
Locations1 site (Erlangen)
StatusRecruiting
StartedDecember 1, 2019
Main results expectedDecember 30, 2024
Study endsDecember 30, 2026
Registry record updatedDecember 3, 2019
Trial IDNCT03975322 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 to 80 with a diagnosis of oral leukoplakia.

Probably not a fit

Patients with invasive carcinoma of the oral cavity or a history of oral cavity carcinoma will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the potential of MAGE-A gene family antigens as predictive markers for the malignant transformation of oral leukoplakia (OLP). Given that a significant percentage of oral squamous cell carcinomas (OSCC) arise from OLP, early detection is crucial for improving patient outcomes. The study will assess the presence of MAGE-A antigens in patients diagnosed with OLP to determine their risk of developing OSCC. By identifying high-risk lesions, the study seeks to enhance therapeutic decision-making and potentially guide immunotherapy approaches.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and management of patients at risk for oral squamous cell carcinoma.

How similar studies have gone: While the use of MAGE-A as a predictive marker is promising, this approach is relatively novel and has not been extensively tested in similar studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg
    Erlangen, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.