Trials
Search / Trial NCT06438939

NBI for Early Diagnosis of OPMD/OSCC

Launched by CARDARELLI HOSPITAL · May 27, 2024

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Narrow Band Imaging Oscc Opmd Nbi

ClinConnect Summary

Introduction Oral squamous cell carcinoma (OSCC) is a malignant condition arising from the mucosal lining of the mouth. It is the most frequent malignancy that affects the oral cavity, with more than 350,000 new incident cases estimated worldwide yearly, causing over 150,000 deaths in 2020.

The 5-year overall survival rate of OSCC - around 60%- has not significantly improved during the last decades, despite general clinical and therapeutic advances. Considering that patients with initial stages (I-II) of OSCC show survival rates of 80-90%, while advanced-stages (III-IV) survival stands low...

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

About Cardarelli Hospital

Cardarelli Hospital is a leading healthcare institution renowned for its commitment to excellence in patient care and clinical research. Located in Naples, Italy, the hospital is equipped with state-of-the-art facilities and a multidisciplinary team of healthcare professionals dedicated to advancing medical knowledge and improving treatment outcomes. As a clinical trial sponsor, Cardarelli Hospital focuses on innovative research initiatives that aim to address critical healthcare challenges, enhance therapeutic options, and contribute to the global medical community. With a strong emphasis on ethical standards and patient safety, Cardarelli Hospital plays a pivotal role in facilitating clinical trials that drive scientific progress and foster collaboration among researchers and healthcare providers.

Locations

Napoli, , Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0