NBI for Early Diagnosis of OPMD/OSCC

Launched by CARDARELLI HOSPITAL · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a technique called Narrow Band Imaging (NBI) to see if it is better than the usual method of examining the mouth with regular white light for detecting early signs of oral cancer and related conditions. The goal is to find out if NBI can help doctors spot potential problems earlier, which could lead to better treatment outcomes and increased survival rates for patients with oral squamous cell carcinoma (OSCC) and other potentially malignant disorders (OPMD).

To participate in this trial, individuals must be between the ages of 65 and 74 and have certain oral conditions, such as soft tissue lesions or a history of OPMD, which includes conditions like leukoplakia or oral lichen planus. Some potential participants may also have a history of head and neck cancers. During the trial, participants will undergo examinations using both NBI and the traditional white light method to compare the effectiveness of each approach. It's important to note that not everyone will be eligible, especially those who don’t need a biopsy or have conditions that prevent them from undergoing the necessary procedures. The trial is not yet recruiting participants, but it aims to provide valuable insights into improving early diagnosis of oral cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with soft tissue, mucosal lesions of the oral cavity, who arrive for an initial first diagnosis (group 1);
• • Patients with history OPMD (clinically evident lesion/s group 2a, lesion/s excised group 2b), who are in follow-up (OPMDs included are eg. Leukoplakia, erythroleukoplakia, erythroplakia, oral lichen planus, oral lichenoid lesion);
• • Patients with history of HNSCC (OSCC group 3a, sinonasal, nasopharynx, oropharynx, larynx, oesophagus group 3b);
• • High risk (see above) individuals with no known oral mucosal disease (group 4);
• Exclusion Criteria:
• • patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I)
• • patients who, despite indication, were not suitable to undergo biopsy given his / her systemic conditions