Predictive Value of GOCCLES® (Glasses for Oral Cancer Curing Light Exposed Screening), Device for Early Diagnosis of Oral Potentially Malignant Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Biopsy and histopathological analysis
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than
- •Patients that present oral mucosa injuries compatible with OPMD.
- •Patients that understand the purpose of the study and express consent
排除标准
- •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
结局指标
主要结局
Biopsy and histopathological analysis
时间窗: 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.
Oral examination with GOCCLES device
时间窗: 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.
Intraoral examination. Location of the lesion
时间窗: 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
时间窗: 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
时间窗: 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
Toluidine blue staining of the lesion
时间窗: 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.
次要结局
未报告次要终点
研究者
Rocío Teresa Martín Munoz
Bachelor of Dentistry and Specialist in Oral Medicine
Universidad Rey Juan Carlos