Clinical trial NCT05562375: Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders
Official title: Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Potentially Malignant Disorders
Oral Cancer
Keywords: GOCCLES
Autofluorescence
Oral cancer
Oral dysplasia
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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:

1. Specific location of the injury or injuries will be taken.
2. Its maximum size will be measured.
3. Photographic record with Canon EFS 60mm camera and Canon Macro Ring Lite MR-14EX ring flash.
4. 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.
5. Notes will be taken on the location and size of the injury observed with the device.
6. Image register using the GOCCLES® photographic filter for mobile devices. The same light source will be used.
7. 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.
8. Notes on the and pictures will be taken on the location and size of the injury.
9. The area to biopsy will be chosen, and, using local anaesthesia, it will be resected.
10. 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.
11. 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.

Eligibility 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

Primary outcomes:
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
measure: Intraoral examination. Size 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
measure: Intraoral examination. Photographic record
timeFrame: This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
measure: Oral examination with GOCCLES device
timeFrame: 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.
measure: Toluidine blue staining of the lesion
timeFrame: 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.
measure: Biopsy and histopathological analysis
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos de Madrid
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos de Madrid
name: Rocío Teresa Martín Muñoz
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Rey Juan Carlos de Madrid
name: Antonio Francisco López Sánchez
role: STUDY_DIRECTOR
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