NCT00655421

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Oral Cancer
• Precancerous Conditions

Interventions

Type	Name	Description
OTHER	Unaided Visual Inspection	Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
DEVICE	VelScope	Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
OTHER	Toluidine Blue Assisted Oral Examination	Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-04-09
• Last updated: 2009-07-03

Locations

1 site across 1 country: India