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Purpose <p>Oral cancer is the sixteenth most common malignancy globally and is characterized by a 5-year survival rate of less than 40%. In recent years, innovative methods have been developed to facilitate its early diagnosis, including the GOCCLES® device. This study aimed to evaluate the diagnostic value of GOCCLES® in detecting dysplasia in oral potentially malignant disorders (OPMDs) and diagnosing oral squamous cell carcinoma (OSCC). Additionally, this study sought to compare the device’s efficacy with toluidine blue (TB) staining and assess the value of combining both methods.</p> Methods <p>Patients clinically diagnosed with OPMDs or OSCC were included. Anamnesis, oral examination, inspection with GOCCLES®, and TB staining were performed. Finally, lesions were biopsied and the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of each technique were determined.</p> Results <p>Thirty-two patients were included in this study. The GOCCLES® device had a sensitivity of 33.3%, specificity of 40%, PPV of 25%, NPV of 50%, and accuracy of 37.5%. For TB staining, the sensitivity, specificity, PPV, NPV, and accuracy were 58.3%, 85%, 70%, 77.27%, and 75%, respectively. The respective values for the combined method were 44.4%, 77.78%, 66.67%, 58.33%, and 61.11%.</p> Conclusions <p>GOCCLES® and TB staining could help in the early diagnosis of OSCC and OPMDs, but a biopsy of the lesion remains essential for obtaining a definitive diagnosis.</p>

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Predictive value of a non-invasive autofluorescence-based device (GOCCLES®) in the early diagnosis of oral potentially malignant disorders and oral cancer: a cross-sectional study

  • 期刊论文

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  • 发表日期：

    2025年11月22日

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  • Rocío Teresa Martín-Muñoz,
  • Jesús Rodríguez-Molinero,
  • Blanca del Carmen Migueláñez-Medrán,
  • Juan Antonio Ruiz-Roca,
  • Pía López-Jornet,
  • Rosario María Ramírez-Puerta,
  • Antonio Francisco López-Sánchez

摘要

Purpose

Oral cancer is the sixteenth most common malignancy globally and is characterized by a 5-year survival rate of less than 40%. In recent years, innovative methods have been developed to facilitate its early diagnosis, including the GOCCLES® device. This study aimed to evaluate the diagnostic value of GOCCLES® in detecting dysplasia in oral potentially malignant disorders (OPMDs) and diagnosing oral squamous cell carcinoma (OSCC). Additionally, this study sought to compare the device’s efficacy with toluidine blue (TB) staining and assess the value of combining both methods.

Methods

Patients clinically diagnosed with OPMDs or OSCC were included. Anamnesis, oral examination, inspection with GOCCLES®, and TB staining were performed. Finally, lesions were biopsied and the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of each technique were determined.

Results

Thirty-two patients were included in this study. The GOCCLES® device had a sensitivity of 33.3%, specificity of 40%, PPV of 25%, NPV of 50%, and accuracy of 37.5%. For TB staining, the sensitivity, specificity, PPV, NPV, and accuracy were 58.3%, 85%, 70%, 77.27%, and 75%, respectively. The respective values for the combined method were 44.4%, 77.78%, 66.67%, 58.33%, and 61.11%.

Conclusions

GOCCLES® and TB staining could help in the early diagnosis of OSCC and OPMDs, but a biopsy of the lesion remains essential for obtaining a definitive diagnosis.