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

Sponsor

Tata Memorial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00655421

Collaborator

American Cancer Society, Inc. (Other), Emory University (Other)

329

Enrollment

Location

Arms

Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer Precancerous Conditions	Other: Unaided Visual Inspection Device: VelScope Other: Toluidine Blue Assisted Oral Examination	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

329 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Screening

Official Title:

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.

Study Start Date :

Apr 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Unaided

Unaided Visual Inspection of the Oral Cavity

Other: Unaided Visual Inspection

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

Experimental: VelScope

VelScope assisted examination of the oral cavity

Device: VelScope

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

Experimental: Toluidine

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

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

Outcome Measures

Primary Outcome Measures

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

To estimate the test characteristics of each of the three oral cancer screening techniques. [Six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.