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

Phase 3

• Conditions: Oral Cancer; Precancerous Conditions
• Interventions: Other: Unaided Visual Inspection; Device: VelScope; Other: Toluidine Blue Assisted Oral Examination

• Registration Number: NCT00655421
• Lead Sponsor: Tata Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-02
• Last Update Posted: 2009-07-03
• Primary Completion: 2009-09
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 329

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unaided	Unaided Visual Inspection	Unaided Visual Inspection of the Oral Cavity
VelScope	VelScope	VelScope assisted examination of the oral cavity
Toluidine	Toluidine Blue Assisted Oral Examination	Examination of oral cavity after the local application of Toluidine Blue dye

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To estimate the test characteristics of each of the three oral cancer screening techniques.	Six months

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, Maharashtra, India