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

Oral Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00655421
• Other study ID #: 391
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: July 2, 2009
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 329
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer
• Precancerous Conditions

Intervention

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

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
Tata Memorial Hospital	American Cancer Society, Inc., Emory University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To estimate the test characteristics of each of the three oral cancer screening techniques.		Six months	No

External Links

•   Customized optical device helps dentists to detect oral cancer