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Recruiting NCT05562375

Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders

Trial Parameters

Condition Oral Potentially Malignant Disorders
Sponsor Universidad Rey Juan Carlos
Study Type INTERVENTIONAL
Phase N/A
Enrollment 73
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-01-08
Completion 2026-06-30
Interventions
GOCCLESToluidine blue stainBiopsy

Brief Summary

Oral potentially malignant disorders (OPMDs) are chronic pathologies which can suffer dysplastic alterations and evolve into oral cancer. The diagnosis of those pathologies is commonly done by visual inspection, which is not capable of determining the presence or not of dysplasia. Furthermore, this type of diagnosis depends greatly on the expertise and training of the professional. In recent years, new methods that can help early oral cancer diagnosis have been developed. A new device has been commercialized, named GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), based on the autofluorescence principle. The hypothesis of this study is that GOCCLES® device could be an effective tool to help in early detection of oral cancer.

Eligibility Criteria

Inclusion Criteria: * Patients older than 18. * Patients that present oral mucosa injuries compatible with OPMD. * Patients that understand the purpose of the study and express consent Exclusion Criteria: * Patients that don't have the capability to express consent. * Patients with systemic pathologies that contraindicate a biopsy. * Patients with a recent biopsy at the oral cavity

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