Oral Cancer Screening in Mumbai, India by Primary Health Care Workers

Tata Memorial Hospital329 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

329

Conditions

Oral Cancer Precancerous Conditions

Interventions

Unaided Visual InspectionOTHER

Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker

VelScopeDEVICE

Examination of the oral cavity through a VelScope by trained Primary Health Care Worker

Toluidine Blue Assisted Oral ExaminationOTHER

Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tata Memorial Hospital

Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

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

To estimate the test characteristics of each of the three oral cancer screening techniques.

Time frame: Six months

Data from ClinicalTrials.gov

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