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

Primary Purpose

Oral Potentially Malignant Disorders, Oral Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GOCCLES
Toluidine blue stain
Biopsy
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oral Potentially Malignant Disorders focused on measuring GOCCLES, Autofluorescence, Oral cancer, Oral dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Rey Juan Carlos de MadridRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2022
Last Updated
September 30, 2022
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05562375
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Potentially Malignant Disorders, Oral Cancer
Keywords
GOCCLES, Autofluorescence, Oral cancer, Oral dysplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
GOCCLES
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Toluidine blue stain
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
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
Primary Outcome Measure Information:
Title
Intraoral examination. Location of the lesion
Description
Intraoral examination of the injury with white light. Information about location will be recorded in a data collection document, individual for each patient.
Time Frame
This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
Title
Intraoral examination. Size of the lesion
Description
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.
Time Frame
This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
Title
Intraoral examination. Photographic record
Description
Photographs of the lesion will be recorded with a Canon EFS 60 mm camera and Canon Macro Ring Lite MR-14EX ring flash
Time Frame
This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
Title
Oral examination with GOCCLES device
Description
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.
Time Frame
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.
Title
Toluidine blue staining of the lesion
Description
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.
Time Frame
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.
Title
Biopsy and histopathological analysis
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rocío Teresa Martín Muñoz
Phone
645468417
Email
rt.martin@alumnos.urjc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocío Teresa Martín Muñoz
Organizational Affiliation
Universidad Rey Juan Carlos de Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Francisco López Sánchez
Organizational Affiliation
Universidad Rey Juan Carlos de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Rey Juan Carlos de Madrid
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocío Teresa Martín Muñoz
Phone
645468417
Email
rt.martin@alumnos.urjc.es
First Name & Middle Initial & Last Name & Degree
María Victoria Fuentes Fuentes
First Name & Middle Initial & Last Name & Degree
Antonio Francisco López Sánchez
First Name & Middle Initial & Last Name & Degree
Blanca del Carmen Migueláñez Medrán
First Name & Middle Initial & Last Name & Degree
Jesús Rodríguez Molinero
First Name & Middle Initial & Last Name & Degree
Rocío Teresa Martín Muñoz

12. IPD Sharing Statement

Plan to Share IPD
No
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Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders

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