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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Oral Cancer, Precancerous Conditions

Intervention / Treatment
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* Other: Unaided Visual Inspection
* Device: VelScope
* Other: Toluidine Blue Assisted Oral Examination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unaided<br>Unaided Visual Inspection of the Oral Cavity | Other: Unaided Visual Inspection<br>* Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker<br>|
| Experimental: VelScope<br>VelScope assisted examination of the oral cavity | Device: VelScope<br>* Examination of the oral cavity through a VelScope by trained Primary Health Care Worker<br>|
| Experimental: Toluidine<br>Examination of oral cavity after the local application of Toluidine Blue dye | Other: Toluidine Blue Assisted Oral Examination<br>* Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the test characteristics of each of the three oral cancer screening techniques. |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, oral precancers, tobacco users, VELScope, Visual Inspection, Toluidine Blue