NCT06438939Not yet recruiting
NBI for Early Diagnosis of OPMD/OSCC
Narrow Band Imaging (NBI) for Early Diagnosis of Oral Squamous Cell Carcinoma (OSCC) and Oral Potentially Malignant Disorders (OPMD)
Source: ClinicalTrials.gov · Last updated 3 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Early detection - possibly at its pre-malignant stages (Oral Potentially Malignant Disorders, OPMD) - with periodic surveillance is thus fundamental for limiting disease burden, hopefully reducing the incidence of advanced stages OSCC and increasing survival. Narrow Band Imaging (NBI) has proved itself as promising tool for helping clinician both for diagnosis and therapy. Yet, there is no definitive scientific evidence that NBI is superior to common oral examination with white light (WLOE) for diagnosing OSCC/OPMD. We thus propose a randomised clinical trial understand its role in this field.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 20 May 2024
- Start date
- 30 Sept 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Cardarelli Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT06438939
What you commit to
- Study type: Interventional
- Planned participants: 480
- From 30 Sept 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- patients who, despite indication, were not suitable to undergo biopsy given his / her systemic conditions
Other
- patients who did not need a biopsy nor after WLOE (e.g. normal mucosa, anatomical variation) nor after NBI (pattern I)
Who the study is looking for
- 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);
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Agostino Guida Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.