Using GOCCLES® device for early diagnosis of oral cancer
Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
This study is testing if the GOCCLES® device can help doctors find oral cancer and related conditions earlier than traditional methods in patients with mouth injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Rey Juan Carlos Academic / other |
| Locations | 1 site (Alcorcón, Madrid) |
| Trial ID | NCT05562375 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the GOCCLES® device, which utilizes autofluorescence technology, in the early detection of oral potentially malignant disorders (OPMDs) and oral cancer. Patients presenting with oral mucosa injuries compatible with OPMDs will undergo a series of examinations, including visual inspection, GOCCLES® assessment, and blue toluidine staining, followed by biopsy of the affected areas. The study will compare the diagnostic accuracy of the GOCCLES® device with traditional methods to determine its predictive value. A total of 73 patients will be recruited from the oral medicine service at the Universidad Rey Juan Carlos in Madrid.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with oral mucosa injuries indicative of potentially malignant disorders.
Not a fit: Patients who are unable to provide consent or have systemic conditions that contraindicate a biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of oral cancer, improving patient outcomes.
How similar studies have performed: While the use of autofluorescence in oral diagnostics is emerging, this specific application with the GOCCLES® device is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alcorcón, Madrid
- Universidad Rey Juan Carlos de Madrid — Alcorcón, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Rocío Teresa Martín Muñoz — Universidad Rey Juan Carlos de Madrid
- Study coordinator: Rocío Teresa Martín Muñoz
- Email: rt.martin@alumnos.urjc.es
- Phone: 645468417
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.