NBI for Early Diagnosis of OPMD/OSCC

NCT06438939 | Not Yet Recruiting

• 1 other identifier: 06/24
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Squamous Cell Carcinoma; Oral Potentially Malignant Disorder

Keywords

narrow band imaging; OSCC; OPMD; NBI

Outcome Measures

Primary Outcomes (1)

• Detection rates of OPMD and OSCC

  Comparison of detection rates WLOE vs. NBI

  through study completion, an average of 2 year

Secondary Outcomes (4)

• sensitivity

  through study completion, an average of 2 year

• specificity

  through study completion, an average of 2 year

• NPV

  through study completion, an average of 2 year

• PPV

  through study completion, an average of 2 year

Study Arms (2)

White Light Oral Examination (WLOE)

ACTIVE COMPARATOR

Patients will undergo commone WLOE examination prior to do a required biopsy (see protocol for patients characteristics).

Other: Biopsy for diagnostical purposes

Narrow Band Imaging (NBI)

EXPERIMENTAL

Patients will have their biopsy guided by NBI (see protocol for patients characteristics).

Other: Biopsy for diagnostical purposes

Interventions

Biopsy for diagnostical purposes OTHER

Incisional biopsy is the current golden standard for OPMD/OSCC diagnosis. Yet, the site it shall be performed is choosen by clinician at naked eyes. We will compare and study the results of performing the common golden standard biopsy site when guided by NBI.

Narrow Band Imaging (NBI); White Light Oral Examination (WLOE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardarelli Hospital: lead

Study Sites (1)

Agostino Guida

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 3, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)