Status:

COMPLETED

Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care

Lead Sponsor:

Ohio State University Comprehensive Cancer Center

Conditions:

Lip and Oral Cavity Squamous Cell Carcinoma

Oral Cavity Verrucous Carcinoma

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescen...

Detailed Description

PRIMARY OBJECTIVES: I. To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection in oral examination. II. Efficacy of the VELscope in identifying dysplastic (premalign...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • HIGH-RISK POPULATION:
  • 33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
  • GENERAL POPULATION:
  • 250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate

Exclusion

    Key Trial Info

    Start Date :

    November 11 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 28 2019

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT01816841

    Start Date

    November 11 2008

    End Date

    December 28 2019

    Last Update

    January 30 2020

    Active Locations (1)

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    Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, United States, 43210