Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
Primary Purpose
Oral Cancer, Precancerous Conditions
Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Unaided Visual Inspection
VelScope
Toluidine Blue Assisted Oral Examination
Sponsored by
About this trial
This is an interventional screening trial for Oral Cancer focused on measuring screening, oral precancers, tobacco users, VELScope, Visual Inspection, Toluidine Blue
Eligibility 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.
Sites / Locations
- Tata Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Unaided
VelScope
Toluidine
Arm Description
Unaided Visual Inspection of the Oral Cavity
VelScope assisted examination of the oral cavity
Examination of oral cavity after the local application of Toluidine Blue dye
Outcomes
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.
Secondary Outcome Measures
To estimate the test characteristics of each of the three oral cancer screening techniques.
Full Information
NCT ID
NCT00655421
First Posted
April 3, 2008
Last Updated
July 2, 2009
Sponsor
Tata Memorial Hospital
Collaborators
American Cancer Society, Inc., Emory University
1. Study Identification
Unique Protocol Identification Number
NCT00655421
Brief Title
Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tata Memorial Hospital
Collaborators
American Cancer Society, Inc., Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Precancerous Conditions
Keywords
screening, oral precancers, tobacco users, VELScope, Visual Inspection, Toluidine Blue
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
329 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unaided
Arm Type
Experimental
Arm Description
Unaided Visual Inspection of the Oral Cavity
Arm Title
VelScope
Arm Type
Experimental
Arm Description
VelScope assisted examination of the oral cavity
Arm Title
Toluidine
Arm Type
Experimental
Arm Description
Examination of oral cavity after the local application of Toluidine Blue dye
Intervention Type
Other
Intervention Name(s)
Unaided Visual Inspection
Intervention Description
Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
Intervention Type
Device
Intervention Name(s)
VelScope
Intervention Description
Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
Intervention Type
Other
Intervention Name(s)
Toluidine Blue Assisted Oral Examination
Intervention Description
Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To estimate the test characteristics of each of the three oral cancer screening techniques.
Time Frame
Six months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra S Shastri, MD
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
12. IPD Sharing Statement
Links:
URL
http://www.medicalnewstoday.com
Description
Customized optical device helps dentists to detect oral cancer
Learn more about this trial
Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
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