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

Study Overview
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Brief Summary
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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.

Detailed Description
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The main objective of this study is to establish GOCCLES® autofluorescence method predictive value in early diagnostic of malignant oral disorders and/or potentially malignant oral cavities. The secondary objectives are comparing the match in zone detection between this method and blue toluidine staining, and valuing if blue toluidine staining brings additional information to the dysplastic injuries diagnoses when combined to the GOCCLES® device. This study will follow the STARD (Standards for Reporting of Diagnostic Accuracy Studies) guideline. It is intended to recruit 73 patients from the oral medicine service at the university clinic of Rey Juan Carlos University in Madrid, that present a compatible clinic diagnostic 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. DETAILED PROCEDURE: Specific location of the injury or injuries will be taken. Its maximum size will be measured. Photographic record with Canon EFS 60mm camera and Canon Macro Ring Lite MR-14EX ring flash. Inspection using GOCCLES®. An UV light source will be administered, with Sdi Radii Xpert polymerization lamp with a potency of 1500mW/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. 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. The area to biopsy will be chosen, and, using local anaesthesia, it will be resected. The sample or samples will be sent to the Oral and Maxillofacial Pathology Diagnostic Service of the University of the Basque Country, properly preserved in formalin and with the corresponding report. In addition, the following data of each patient will be registred: age, sex, harmful habits, medical history of interest, type of injury, location of the injury, size of the injury and presumptive diagnosis. 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. The patient will be called after 7-15 days, to receive the results and the retiring of the suture if required, and to start treatment in cases which it is needed. A lesion will be considered positive if, when using GOCCLES® device, a loss of fluorescence is observed in an area or areas of the lesion, that is, when a brownish, brown or dark brown area or areas are observed. A lesion will be considered to be positive for toluidine blue staining when, after carrying out the sequence described by Mashberg, an intense blue staining is produced in an area or areas of the lesion A positive result will be considered after performing biopsy in those cases in which the anatomopathological analysis indicates the presence of dysplasia, whatever its grade, or the presence of malignant transformation.

Official Title
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Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders

Conditions
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Oral Potentially Malignant Disorders, Oral Cancer

Intervention / Treatment
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* Device: GOCCLES
* Diagnostic Test: Toluidine blue stain
* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>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<br>* 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.<br>Diagnostic Test: Toluidine blue stain<br>* 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.<br>Procedure: Biopsy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GOCCLES, Autofluorescence, Oral cancer, Oral dysplasia