Oral Potentially Malignant DisordersNCT05562375
Predictive Value of GOCCLES® Device for Early Diagnosis of Oral Potentially Malignant Disorders
A study testing GOCCLES, Toluidine blue stain and Biopsy in people with Oral Potentially Malignant Disorders and Oral Cancer, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Potentially Malignant Disorders, Oral Cancer
- What is being tested?
- GOCCLES, Toluidine blue stain and Biopsy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18.
- Patients that present oral mucosa injuries compatible with OPMD.
- Patients that understand the purpose of the study and express consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos de Madrid
Alcorcón, Madrid, 28922
Rocío Teresa Martín Muñoz, 645468417, rt.martin@alumnos.urjc.es
María Victoria Fuentes Fuentes
About this study
Official title: Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
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.
Read more
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.
Read the 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.
- Conditions
- Oral Potentially Malignant Disorders, Oral Cancer
- Being tested
- GOCCLES, Toluidine blue stain, Biopsy
- Keywords
- GOCCLES, Autofluorescence, Oral cancer, Oral dysplasia
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOCCLESDevice
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.
Toluidine blue stainDiagnostic 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.
BiopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: GOCCLES; Diagnostic Test: Toluidine blue stain; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start8 Jan 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Oral Potentially Malignant DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Teresa Martín Munoz, Universidad Rey Juan Carlos
- Investigators
- Rocío Teresa Martín Muñoz, Principal investigator, Universidad Rey Juan Carlos de MadridAntonio Francisco López Sánchez, Study director, Universidad Rey Juan Carlos de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562375
- Sponsor's protocol ID
- 3011202123121
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Scully 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.
PubMed 19249237Warnakulasuriya 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.
PubMed 19946320Warnakulasuriya 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.
PubMed 18804401McCullough 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.
PubMed 20553246Mignogna 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.
PubMed 15100581Mello 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.
PubMed 29738071Warnakulasuriya 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.
PubMed 17944749Farah 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.
PubMed 21818819Fedele S. Diagnostic aids in the screening of oral cancer. Head Neck Oncol. 2009 Jan 30;1:5. doi: 10.1186/1758-3284-1-5.
PubMed 19284694Scheer 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.
PubMed 21429774Abati 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.
PubMed 33302498Moro 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.
PubMed 26900252
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
- ClinicalTrials.gov ID
- NCT05562375
- Acronym / sponsor ID
- 3011202123121
- Conditions
- Oral Potentially Malignant Disorders, Oral Cancer
- Keywords
- GOCCLES, Autofluorescence, Oral cancer, Oral dysplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: GOCCLES, Diagnostic Test: Toluidine blue stain, Procedure: Biopsy73 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18.
- Patients that present oral mucosa injuries compatible with OPMD.
- Patients that understand the purpose of the study and express consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOCCLESInspection 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. | Device | Patients |
| Toluidine blue stainTo 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. | Diagnostic test | Patients |
| BiopsyThe 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 | Procedure or surgery | Patients |
Primary outcome
Intraoral examination. Location of the lesion
Time frame: This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
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
Time frame: This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
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
Time frame: This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes
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
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.
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
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.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 19249237Scully 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.
- Background: PubMed 19946320Warnakulasuriya 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.
- Background: PubMed 18804401Warnakulasuriya 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.
- Background: PubMed 20553246McCullough 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.
- Background: PubMed 15100581Mignogna 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.
- Background: PubMed 29738071Mello 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.
- Background: PubMed 17944749Warnakulasuriya 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.
- Background: PubMed 21818819Farah 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.
- Background: PubMed 19284694Fedele S. Diagnostic aids in the screening of oral cancer. Head Neck Oncol. 2009 Jan 30;1:5. doi: 10.1186/1758-3284-1-5.
- Background: PubMed 21429774Scheer 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.
- Background: PubMed 33302498Abati 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.
- Individual participant dataSharing planned: No
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Active, not recruitingEarly Phase 1
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Dysplasia, Lip and Oral Cavity Carcinoma
Not yet recruiting
Feasibility and Validation of an Automated AI-Enabled Deep Ultraviolet (DUV) Cytology Platform for Point-of-Care Oral Cancer Triage
Oral Potentially Malignant Lesions, Oral Potentially Malignant Disorders
Enrolling by invitation
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocío Teresa Martín Muñoz principal investigator
Universidad Rey Juan Carlos de Madrid
Antonio Francisco López Sánchez study director
Universidad Rey Juan Carlos de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOCCLES, Toluidine blue stain and Biopsy in people with Oral Potentially Malignant Disorders and Oral Cancer, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocío Teresa Martín Muñoz (645468417, rt.martin@alumnos.urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoral examination. Location of the lesion (time frame: This procedure will be realised in the first appointment, at day 1, and it will take a time of five minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562375, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.