Trial Title:
Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders
NCT ID:
NCT05562375
Condition:
Oral Potentially Malignant Disorders
Oral Cancer
Conditions: Official terms:
Mouth Neoplasms
Tolonium Chloride
Conditions: Keywords:
GOCCLES
Autofluorescence
Oral cancer
Oral dysplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
GOCCLES
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.
Arm group label:
Patients
Intervention type:
Diagnostic Test
Intervention name:
Toluidine blue stain
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.
Arm group label:
Patients
Intervention type:
Procedure
Intervention name:
Biopsy
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
Arm group label:
Patients
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universidad Rey Juan Carlos de Madrid
Address:
City:
Alcorcón
Zip:
28922
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Rocío Teresa Martín Muñoz
Phone:
645468417
Email:
rt.martin@alumnos.urjc.es
Investigator:
Last name:
María Victoria Fuentes Fuentes
Email:
Sub-Investigator
Investigator:
Last name:
Antonio Francisco López Sánchez
Email:
Sub-Investigator
Investigator:
Last name:
Blanca del Carmen Migueláñez Medrán
Email:
Sub-Investigator
Investigator:
Last name:
Jesús Rodríguez Molinero
Email:
Sub-Investigator
Investigator:
Last name:
Rocío Teresa Martín Muñoz
Email:
Principal Investigator
Start date:
January 8, 2022
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Universidad Rey Juan Carlos
Agency class:
Other
Source:
Universidad Rey Juan Carlos
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05562375
