Clinical trial · Interventional
Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders
Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oral Potentially Malignant Disorders | Oral Cavity Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| GOCCLES | Device | — | UNRESOLVED |
| Toluidine blue stain | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- description
- 73 patients are to be recruited from the ones that go to the oral medicine service at the university clinic of Rey Juan Carlos in Madrid that present a compatible clinic diagnostic compatible with oral potentially malignant disorders. Each patient will receive first an intraoral exploration, taking note of location and size of the injury. After that, an exploration with the GOCCLES® device will be made, also taking note of the location and size data. Thereafter, the blue toluidine stain will be used, taking note of the size and location of the marked areas. Pictures will be taken through all the steps. Finally, a biopsy will be made of the area or areas the clinic considers and/or marked by the device or the toluidine blue.
- interventionNames
- Device: GOCCLES
- Diagnostic Test: Toluidine blue stain
- Procedure: Biopsy
Primary outcomes (6)
- measure
- Intraoral examination. Location of the lesion
- timeFrame
- This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
- description
- Intraoral examination of the injury with white light. Information about location will be recorded in a data collection document, individual for each patient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDScully C, Bagan J. Oral squamous cell carcinoma overview. Oral Oncol. 2009 Apr-May;45(4-5):301-8. doi: 10.1016/j.oraloncology.2009.01.004. Epub 2009 Feb 26. No abstract available. PMID 19249237
- BACKGROUNDWarnakulasuriya S. Causes of oral cancer--an appraisal of controversies. Br Dent J. 2009 Nov 28;207(10):471-5. doi: 10.1038/sj.bdj.2009.1009. PMID 19946320
- BACKGROUNDWarnakulasuriya S. Global epidemiology of oral and oropharyngeal cancer. Oral Oncol. 2009 Apr-May;45(4-5):309-16. doi: 10.1016/j.oraloncology.2008.06.002. Epub 2008 Sep 18. PMID 18804401
- BACKGROUNDMcCullough MJ, Prasad G, Farah CS. Oral mucosal malignancy and potentially malignant lesions: an update on the epidemiology, risk factors, diagnosis and management. Aust Dent J. 2010 Jun;55 Suppl 1:61-5. doi: 10.1111/j.1834-7819.2010.01200.x. PMID 20553246
- BACKGROUNDMignogna MD, Fedele S, Lo Russo L. The World Cancer Report and the burden of oral cancer. Eur J Cancer Prev. 2004 Apr;13(2):139-42. doi: 10.1097/00008469-200404000-00008. PMID 15100581
- BACKGROUNDMello FW, Miguel AFP, Dutra KL, Porporatti AL, Warnakulasuriya S, Guerra ENS, Rivero ERC. Prevalence of oral potentially malignant disorders: A systematic review and meta-analysis. J Oral Pathol Med. 2018 Aug;47(7):633-640. doi: 10.1111/jop.12726. Epub 2018 Jun 6. PMID 29738071
- BACKGROUNDWarnakulasuriya S, Johnson NW, van der Waal I. Nomenclature and classification of potentially malignant disorders of the oral mucosa. J Oral Pathol Med. 2007 Nov;36(10):575-80. doi: 10.1111/j.1600-0714.2007.00582.x.