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

Tata Memorial Hospital

Status and phase: Unknown; Phase 3

Conditions: Precancerous Conditions; Oral Cancer

Treatments: Other: Unaided Visual Inspection; Device: VelScope; Other: Toluidine Blue Assisted Oral Examination

Study type: Interventional

Funder types: Other

Identifiers

NCT00655421

391

Details and patient eligibility

About

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.

Full 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.

Enrollment: 329 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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329 participants in 3 patient groups

Unaided

Experimental group

Description:

Unaided Visual Inspection of the Oral Cavity

Treatment:

Other: Unaided Visual Inspection

VelScope

Experimental group

Description:

VelScope assisted examination of the oral cavity

Treatment:

Device: VelScope

Toluidine

Experimental group

Description:

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

Treatment:

Other: Toluidine Blue Assisted Oral Examination