RecruitingOBSERVATIONAL

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

This research aims to find an improved way to predict if certain mouth sores, known as oral leukoplakia (OLP), will develop into oral cancer. Currently, predicting this risk is challenging. The study is investigating a new marker called MAGE-A, which is often found in oral cancers and pre-cancerous lesions that become cancerous. Researchers believe MAGE-A could offer a more reliable early warning system. They will study 500 samples of OLP over 3-5 years to see if the presence of MAGE-A helps predict who will get cancer. This could lead to better ways to identify high-risk sores and potentially new treatment approaches.

At a glance

Status

Recruiting

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

500

Start

01 Dec 2019

Estimated completion

30 Dec 2026

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

What is this study about?

Oral cancer is a serious illness, and finding it early is incredibly important to improve treatment success. Many oral cancers begin as mouth sores called oral leukoplakia (OLP). While most OLP are harmless, some can turn into cancer. Predicting which ones will become cancerous is difficult with current methods, and this can be worrying for patients and their doctors.

This study is looking into a new way to identify OLP that are more likely to become cancerous. It focuses on a special marker called MAGE-A. This marker is often found in oral cancers and in OLP lesions that eventually turn cancerous. The researchers believe that detecting MAGE-A could give a much clearer warning signal than our current tests. It might also show changes in the body's protective immune system that happen before cancer develops, which could open new doors for treatment.

The main goal is to see if MAGE-A can become a standard test alongside existing methods, helping doctors better understand a patient's risk. The study will also explore if MAGE-A is linked to changes in the immune system, which could potentially lead to new, less invasive treatments for OLP. By studying 500 patients with OLP over several years, the researchers hope to gather strong evidence for these new approaches.

Key takeaways

This study aims to improve early detection of oral cancer.
It investigates a new marker, MAGE-A, for predicting cancer risk in mouth sores.
The research could lead to more accurate risk assessment for oral leukoplakia.
It might also open doors for new, less invasive treatments.
The study involves monitoring your existing oral leukoplakia over several years.

Who may be eligible?

To join this study, you need to be an adult between the ages of 18 and 80. You must have been diagnosed with oral leukoplakia, which are white patches or sores in your mouth.

This includes people whose oral leukoplakia might be linked to other conditions, such as lichen planus (another skin condition), certain immune system problems, or if you've had other cancers elsewhere in your body (but not oral cancer). You also need to fully understand the study and agree to take part.

You cannot join if you currently have oral cancer, or if you've had oral cancer in the past. Also, if you're unable to give your informed consent for any reason, or if you decide you don't want to participate, you won't be able to join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Do you currently have a diagnosis of oral leukoplakia (white patches in your mouth)?
Have you *not* been diagnosed with oral cancer in your mouth, either now or in the past?
Are you able to understand the study and agree to take part?

Answer every question to see your result.

What does participation involve?

This study involves collecting a biopsy (a small sample) of your oral leukoplakia. This sample will be taken as part of your normal care. You won't need to take any new medications for the study. The researchers will then follow your health for at least 3 years, and potentially up to 5 years, to see if your oral leukoplakia changes over time. Your regular doctor's appointments and any follow-up care for your leukoplakia will continue as normal. The study is mainly observational, meaning they will be looking at what happens over time rather than asking you to do anything extra, beyond providing the biopsy sample. The total duration of monitoring for each patient could be up to 5 years.

Potential risks and benefits

A potential benefit of this study is that it could lead to better ways for doctors to predict if oral leukoplakia might become cancerous, helping to guide more effective care for future patients. For you, there are no direct medical benefits as this is an observational study using a biopsy already planned by your doctor. The main risk involves the standard biopsy procedure, which carries a small risk of discomfort or minor bleeding, similar to any medical procedure of this type. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What is oral leukoplakia?

Oral leukoplakia are white patches inside your mouth that can sometimes, but not always, turn into cancer. Your doctor routinely monitors these patches.

What is MAGE-A?

MAGE-A is a special marker or protein that scientists believe could help predict if an oral leukoplakia might become cancerous.

Will I get any special treatment in this study?

No, this study is about observing and understanding, not offering new treatments directly to participants. Your medical care will continue as usual.

How long will the study follow me?

The study will follow your health for at least 3 years, and possibly up to 5 years, to see how your oral leukoplakia changes over time.

Is a biopsy safe?

A biopsy is a common procedure where a small tissue sample is taken. It has minimal risks, like slight discomfort, similar to other minor medical procedures.

How to find out more

Manuel Weber, MD, DMD

manuel.weber@uk-erlangen.de 0049 9131 85 43749 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.