Oral Cancer Screening in Mumbai, India by Primary Health Care Workers - Full Text View

Sponsors and Collaborators:	Tata Memorial Hospital American Cancer Society Emory University
Information provided by:	Tata Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00655421

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 III

MedlinePlus related topics: Cancer Oral Cancer

Drug Information available for: Tolonium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toludine Blue Application, by Trained Primary Health Care Workers in Mumbai, India.

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 ]

Estimated Enrollment:	300
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Unaided: Experimental 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
VelScope: Experimental VelScope assisted examination of the oral cavity	Device: VelScope Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
Toluidine: Experimental 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

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

Contacts

Contact: Surendra S Shastri, MD

91-22-2415-4379

shastri@vsnl.com

Locations

India, Maharashtra
Tata Memorial Hospital	Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Surendra S Shastri, MD 91-22-2415-4379 shastri@vsnl.com

Sponsors and Collaborators

Tata Memorial Hospital

American Cancer Society

Emory University

Investigators

Principal Investigator:

Surendra S Shastri, MD

Tata Memorial Hospital

More Information

Customized optical device helps dentists to detect oral cancer This link exits the ClinicalTrials.gov site

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

Keywords provided by Tata Memorial Hospital:

screening
oral precancers
tobacco users

VELScope
Visual Inspection
Toludine Blue

Study placed in the following topic categories:

Mouth Diseases
Precancerous Conditions
Oral cancer
Head and Neck Neoplasms
Stomatognathic Diseases

Tolonium Chloride
Heparin
Lip and oral cavity cancer
Mouth Neoplasms
Calcium heparin

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Coagulants
Therapeutic Uses

Hematologic Agents
Heparin Antagonists
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 16, 2009