Overview

This trial is active, not recruiting.

Conditions oral cancer, precancerous conditions
Treatments unaided visual inspection, velscope, toluidine blue assisted oral examination
Phase phase 3
Sponsor Tata Memorial Hospital
Collaborator American Cancer Society, Inc.
Start date April 2008
End date September 2009
Trial size 329 participants
Trial identifier NCT00655421, 391

Summary

A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose screening
Arm
(Experimental)
Unaided Visual Inspection of the Oral Cavity
unaided visual inspection
Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
(Experimental)
VelScope assisted examination of the oral cavity
velscope
Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
(Experimental)
Examination of oral cavity after the local application of Toluidine Blue dye
toluidine blue assisted oral examination
Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker

Primary Outcomes

Measure
To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers.
time frame: six months

Secondary Outcomes

Measure
To estimate the test characteristics of each of the three oral cancer screening techniques.
time frame: Six months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - The study participants will be apparently healthy males with tobacco habit ( present tobacco users and those who have quit within past six months), - above 18 years of age, - attending Preventive Oncology clinic. Exclusion Criteria: - Participants with frank oral cancers will not be recruited in the study.

Additional Information

Official title Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toluidine Blue Application, by Trained Primary Health Care Workers in Mumbai, India.
Principal investigator Surendra S Shastri, MD
Description Oral cancer is the most common cancer among men in India mainly due to the habit of using smokeless tobacco. Pre-cancerous lesions like leukoplakia, melanoplakia, erythroplakia,oral submucous fibrosis and indolent ulcers can be easily detected by periodic examination of the oral cavity of the at-risk populations. Several methods of oral cancer screening have been tried over the past three-four decades with varying success. This study investigates the feasibility of application and compares the test characteristics of three oral cancer screening techniques: Unaided Visual Inspection, VelScope assisted examination and examination after application of Toluidine blue dye by primary health care workers among tobacco users attending a cancer early detection clinic, in Mumbai, India.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Tata Memorial Hospital.