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

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ClinicalTrials.gov Identifier: NCT01816841
Recruitment Status : Active, not recruiting
First Posted : March 22, 2013
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Kristin McNamara, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE March 20, 2013
First Posted Date  ICMJE March 22, 2013
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE November 11, 2008
Actual Primary Completion Date October 3, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2013)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01816841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
Official Title  ICMJE 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 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 (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lip and Oral Cavity Squamous Cell Carcinoma
  • Oral Cavity Verrucous Carcinoma
  • Stage 0 Lip and Oral Cavity Cancer
  • Tongue Cancer
Intervention  ICMJE
  • Procedure: fluorescence imaging
    Undergo DVFE
  • Procedure: biopsy
    Undergo scalpel biopsy
    Other Name: biopsies
  • Procedure: examination
    Undergo COE
    Other Names:
    • Exam
    • Medical Assessment
    • Medical Exam
    • Medical Examination
    • Medical Inspection
  • Procedure: Comparison of surgical margins by COE vs. DVFE
    Surgical margin determination using DVFE
Study Arms  ICMJE
  • Experimental: Diagnostic (COE and DVFE)- Arm I
    Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks.
    Interventions:
    • Procedure: fluorescence imaging
    • Procedure: biopsy
    • Procedure: examination
  • Experimental: Arm II - Comparison of surgical margins using COE vs. DVFE
    Comparison of surgical margins using COE vs. DVFE
    Interventions:
    • Procedure: fluorescence imaging
    • Procedure: biopsy
    • Procedure: examination
    • Procedure: Comparison of surgical margins by COE vs. DVFE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 19, 2018)
68
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2013)
283
Estimated Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date October 3, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01816841
Other Study ID Numbers  ICMJE OSU-08095
NCI-2012-02017 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristin McNamara, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristin McNamara, DDS, MS Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP