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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-09-30

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.

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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.

Conditions

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Oral Cancer Precancerous Conditions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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Unaided

Unaided Visual Inspection of the Oral Cavity

Group Type EXPERIMENTAL

Unaided Visual Inspection

Intervention Type OTHER

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

VelScope

VelScope assisted examination of the oral cavity

Group Type EXPERIMENTAL

VelScope

Intervention Type DEVICE

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

Toluidine

Examination of oral cavity after the local application of Toluidine Blue dye

Group Type EXPERIMENTAL

Toluidine Blue Assisted Oral Examination

Intervention Type OTHER

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

Interventions

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Unaided Visual Inspection

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

Intervention Type OTHER

VelScope

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

Intervention Type DEVICE

Toluidine Blue Assisted Oral Examination

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

Intervention Type OTHER

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.