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

Recruiting now · Not applicable

Conditions studied: Oral Potentially Malignant Disorders, Oral Cancer

In brief

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.

Key facts

Study ID

NCT05562375

Run by

Universidad Rey Juan Carlos

People needed

73

Starts

2022-01-08

Expected to finish

2026-09-30

Last updated by the study team

2022-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients older than 18.
• Patients that present oral mucosa injuries compatible with OPMD.
• Patients that understand the purpose of the study and express consent

You may not qualify if…

• 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

Where it is running

• Universidad Rey Juan Carlos de Madrid — Alcorcón, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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