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

July 2, 2009 updated by: Tata Memorial Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

329

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: six months
six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Collaborators

Emory University
American Cancer Society, Inc.

Investigators

  • Principal Investigator: Surendra S Shastri, MD, Tata Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

July 3, 2009

Last Update Submitted That Met QC Criteria

July 2, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 391

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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