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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Tata Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
American Cancer Society, Inc.
Emory University
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00655421
First received: April 3, 2008
Last updated: July 2, 2009
Last verified: July 2009
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate the test characteristics of each of the three oral cancer screening techniques. [ Time Frame: Six months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655421

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

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Precancerous Conditions
Mouth Neoplasms
Lip Neoplasms
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Tolonium Chloride
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014