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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00655421

Enrollment

329

Registered

2008-04-09

Start date

2008-04-30

Completion date

2009-09-30

Last updated

2009-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cancer, Precancerous Conditions

Keywords

screening, oral precancers, tobacco users, VELScope, Visual Inspection, Toluidine Blue

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.

Interventions

OTHERUnaided Visual Inspection

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

DEVICEVelScope

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

OTHERToluidine Blue Assisted Oral Examination

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Exclusion criteria

* Participants with frank oral cancers will not be recruited in the study.

Design outcomes

Primary

Measure	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

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026