Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
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.
1 other identifier
interventional
329
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJuly 3, 2009
July 1, 2009
1.4 years
April 3, 2008
July 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
six months
Secondary Outcomes (1)
To estimate the test characteristics of each of the three oral cancer screening techniques.
Six months
Study Arms (3)
Unaided
EXPERIMENTALUnaided Visual Inspection of the Oral Cavity
VelScope
EXPERIMENTALVelScope assisted examination of the oral cavity
Toluidine
EXPERIMENTALExamination of oral cavity after the local application of Toluidine Blue dye
Interventions
Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants with frank oral cancers will not be recruited in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tata Memorial Hospitallead
- American Cancer Society, Inc.collaborator
- Emory Universitycollaborator
Study Sites (1)
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surendra S Shastri, MD
Tata Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 9, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 3, 2009
Record last verified: 2009-07