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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Role of Direct Visual Fluorescence in Oral Examination

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 fluorescence, may help find and diagnose oral cancer.

Detailed Summary:

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 (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes.

III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to identify lesions or extent of lesions beyond what is clinically apparent.

OUTLINE:

Patients undergo conventional oral examination (COE) followed by direct visual fluorescence examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel biopsy within 2 weeks.

Sponsor: Ohio State University Comprehensive Cancer Center

Current Primary Outcome:

• Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone [ Time Frame: At the time of examination ]
  Will be evaluated by calculating sensitivity and specificity and their corresponding exact 95% confidence intervals. Association between the two techniques will be assessed using the simple kappa statistic.
• Differences between lesional margins identified by COE and DVFE [ Time Frame: At the time of examination ]
  Will be evaluated using the dependent t-test. In the event that the parametric requirements of this test are not met, the Wilcoxon, matched-pairs, signed-ranks test will be used.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: March 20, 2013
Date Started: November 11, 2008
Date Completion: December 31, 2017
Last Updated: February 22, 2017
Last Verified: February 2017