Identification of Oral Lesions Through an Autofluorescence System

NCT05942794 | Recruiting DMC

• 1 other identifier: 177/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.

Conditions

Oral Leukoplakia; Autofluorescence; Secondary Prevention; Keratosis; Oral Lichen Planus; Oral Cancer; Oral Disease

Keywords

Oral Leukoplakia; Lichen Planus; Squamous cell carcinoma; Keratosis

Outcome Measures

Primary Outcomes (2)

• Clinical change of oral mucosa

  Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance

  baseline and after 21 days

• Fluorescence change of oral mucosa

  Presence of a mucosal area with reduced or increased fluorescence

  baseline and after 21 day

Study Arms (1)

Screening examination

EXPERIMENTAL

All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.

Device: Screening examination

Interventions

Screening examination DEVICE

After an initial clinical visit, all three operators will wear the tissue autofluorescence detection device (GOCCLES®), reporting both observations on their "operator-module".

Screening examination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female;
• Age ≥ 18 years;
• Non-smokers and smokers

You may not qualify if:

• Cancer patients;
• Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Leukoplakia, Oral; Keratosis; Lichen Planus, Oral; Mouth Neoplasms; Mouth Diseases; Lichen Planus; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Central Study Contacts

Luca Ramaglia

CONTACT

+393476912911; luca.ramaglia@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The screening will start after a first oral examination, in order to rule out noticeable mucosal lesions.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 12, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)