Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
This trial is active, not recruiting.
|Conditions||oral cancer, precancerous conditions|
|Treatments||unaided visual inspection, velscope, toluidine blue assisted oral examination|
|Sponsor||Tata Memorial Hospital|
|Collaborator||American Cancer Society, Inc.|
|Start date||April 2008|
|End date||September 2009|
|Trial size||329 participants|
|Trial identifier||NCT00655421, 391|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
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
To estimate the test characteristics of each of the three oral cancer screening techniques.
time frame: Six months
Male participants at least 18 years old.
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.
|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.|
|Principal investigator||Surendra S Shastri, MD|
|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.|
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