Predicting cancer risk in oral leukoplakia using MAGE-A markers
Prospective Prediction of Malignant Transformation of Oral Leukoplakia Using a MAGE-A-based Immunoscore
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 type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Erlangen) |
| Trial ID | NCT03975322 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of oral leukoplakia.
Not a fit: Patients with invasive carcinoma of the oral cavity or a history of oral cavity carcinoma will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Erlangen
- Universitätsklinikum Erlangen, FAU Erlangen-Nürnberg — Erlangen, Germany (Recruiting)
Study contacts
- Study coordinator: Manuel Weber, MD, DMD
- Email: manuel.weber@uk-erlangen.de
- Phone: 0049 9131 85 43749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.