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

NCT05562375 | Recruiting DMC

• 1 other identifier: 3011202123121
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Potentially Malignant Disorders; Oral Cancer

Keywords

GOCCLES; Autofluorescence; Oral cancer; Oral dysplasia

Outcome Measures

Primary Outcomes (6)

• Intraoral examination. Location of the lesion

  Intraoral examination of the injury with white light. Information about location will be recorded in a data collection document, individual for each patient.

  This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes

• Intraoral examination. Size of the lesion

  Intraoral examination of the injury with white light. The size of the injury will be measured with an acetate rule. This information will be recorded in a data collection document, individual for each patient.

  This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes

• Intraoral examination. Photographic record

  Photographs of the lesion will be recorded with a Canon EFS 60 mm camera and Canon Macro Ring Lite MR-14EX ring flash

  This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes

• Oral examination with GOCCLES device

  An UV light source will be administered, with polymerization lamp sdi radii xpert, with a potency of 1500 mW/cm2 and a wavelength of 440-480nm, applied at 20cm of the injury. Notes will be taken on the location and size of the injury observed with the device. Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.

  This procedure will be realised in the first appointment, at day 1, immediately after intraoral examination, and it will take a time of ten minutes.

• Toluidine blue staining of the lesion

  For this procedure, Mashberg technique will be realised. The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water. Information about location and size of the stained area will be recorded in the data collection document. Photographs will be taken with the Canon EFS 60mm camera and Canon Macro Ring Lite MR-14EX ring flash.

  This procedure will be realised in the first appointment, at day 1, immediately after oral examination with GOCCLES device, and it will take a time of fifteen minutes.

• Biopsy and histopathological analysis

  The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. If the area chosen by the investigator as the most adequate one matches the one referred by the GOCCLES® glasses and the toluidine blue, only one biopsy will be made. Otherwise, two or three samples will be taken.

  This procedure will be realised in the first appointment, at day 1, immediately after de toluidine blue staining, and it will take a time of twenty minutes. The patient will be called after 7-15 days, to receive the results.

Study Arms (1)

Patients

EXPERIMENTAL

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.

Device: GOCCLES; Diagnostic Test: Toluidine blue stain; Procedure: Biopsy

Interventions

GOCCLES DEVICE

Inspection using GOCCLES®. An UV light source will be administered, with polymerization lamp sdi radii xpert, with a potency of 1500 mW/cm2 and a wavelength of 440-480nm, applied at 20cm of the injury. Notes will be taken on the location and size of the injury observed with the device. Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.

Patients

Toluidine blue stain DIAGNOSTIC_TEST

To value the toluidine blue diagnosis capacity, the sequence described by Mashberg will be followed: The patient will realize a mouthwash with acetic acid at 1% for 20 seconds. Two using water for 20 seconds. Toluidine blue at 1% will be applied for 20 seconds. New mouthwash with acetic acid for 60 seconds and a final mouthwash with water. Notes on the and pictures will be taken on the location and size of the injury.

Patients

Biopsy PROCEDURE

The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. The specimens will be sent to the oral and maxillofacial pathology diagnostic service of the University of Basque Country for anatomopathological study

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos de Madrid

Alcorcón, Madrid, 28922, Spain

RECRUITING

Related Publications (13)

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  PMID: 33538338 BACKGROUND

• Scully 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 BACKGROUND

• Warnakulasuriya 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 BACKGROUND

• Warnakulasuriya 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 BACKGROUND

• McCullough 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 BACKGROUND

• Mignogna 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 BACKGROUND

• Mello 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 BACKGROUND

• Warnakulasuriya 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.

  PMID: 17944749 BACKGROUND

• Farah CS, McIntosh L, Georgiou A, McCullough MJ. Efficacy of tissue autofluorescence imaging (VELScope) in the visualization of oral mucosal lesions. Head Neck. 2012 Jun;34(6):856-62. doi: 10.1002/hed.21834. Epub 2011 Aug 4.

  PMID: 21818819 BACKGROUND

• Fedele S. Diagnostic aids in the screening of oral cancer. Head Neck Oncol. 2009 Jan 30;1:5. doi: 10.1186/1758-3284-1-5.

  PMID: 19284694 BACKGROUND

• Scheer M, Neugebauer J, Derman A, Fuss J, Drebber U, Zoeller JE. Autofluorescence imaging of potentially malignant mucosa lesions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 May;111(5):568-77. doi: 10.1016/j.tripleo.2010.12.010. Epub 2011 Mar 22.

  PMID: 21429774 BACKGROUND

• Abati S, Bramati C, Bondi S, Lissoni A, Trimarchi M. Oral Cancer and Precancer: A Narrative Review on the Relevance of Early Diagnosis. Int J Environ Res Public Health. 2020 Dec 8;17(24):9160. doi: 10.3390/ijerph17249160.

  PMID: 33302498 BACKGROUND

• Moro A, De Waure C, Di Nardo F, Spadari F, Mignogna MD, Giuliani M, Califano L, Gianni AB, Cardarelli L, Celentano A, Bombeccari G, Pelo S. The GOCCLES(R) medical device is effective in detecting oral cancer and dysplasia in dental clinical setting. Results from a multicentre clinical trial. Acta Otorhinolaryngol Ital. 2015 Dec;35(6):449-54. doi: 10.14639/0392-100X-922.

  PMID: 26900252 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rocío Teresa Martín Muñoz

  Universidad Rey Juan Carlos de Madrid

  PRINCIPAL INVESTIGATOR

• Antonio Francisco López Sánchez

  Universidad Rey Juan Carlos de Madrid

  STUDY DIRECTOR

Central Study Contacts

Rocío Teresa Martín Muñoz

CONTACT

645468417; rt.martin@alumnos.urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Dentistry and Specialist in Oral Medicine

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 30, 2022
• Study Start: January 8, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)