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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Tata Memorial Hospital.
Recruitment status was:  Active, not recruiting
American Cancer Society, Inc.
Emory University
Information provided by:
Tata Memorial Hospital Identifier:
First received: April 3, 2008
Last updated: July 2, 2009
Last verified: July 2009
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 Intervention Phase
Oral Cancer
Precancerous Conditions
Other: Unaided Visual Inspection
Device: VelScope
Other: Toluidine Blue Assisted Oral Examination
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:

Further study details as provided by Tata Memorial Hospital:

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. [ Time Frame: six months ]

Secondary Outcome Measures:
  • To estimate the test characteristics of each of the three oral cancer screening techniques. [ Time Frame: Six months ]

Enrollment: 329
Study Start Date: April 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Exclusion Criteria:

  • Participants with frank oral cancers will not be recruited in the study.
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Please refer to this study by its identifier: NCT00655421

Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
American Cancer Society, Inc.
Emory University
Principal Investigator: Surendra S Shastri, MD Tata Memorial Hospital
  More Information

Additional Information:
Responsible Party: Dr.S.S.Shastri/Professor and Head, Department,Preventive Oncology, Tata Memorial Hospital, Mumbai, India Identifier: NCT00655421     History of Changes
Other Study ID Numbers: 391
Study First Received: April 3, 2008
Last Updated: July 2, 2009

Keywords provided by Tata Memorial Hospital:
oral precancers
tobacco users
Visual Inspection
Toluidine Blue

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Precancerous Conditions
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Tolonium Chloride
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017