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.
18 Years
N/A
Male
Oral Cancer, Precancerous Conditions
Trial Information
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.
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening
Outcome Measure:
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.
Outcome Time Frame:
six months
Safety Issue:
No
Principal Investigator
Surendra S Shastri, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tata Memorial Hospital
Authority:
India: Indian Council of Medical Research
Study ID:
391
NCT ID:
NCT00655421
Start Date:
April 2008
Completion Date:
September 2009
Related Keywords:
- Oral Cancer
- Precancerous Conditions
- screening
- oral precancers
- tobacco users
- VELScope
- Visual Inspection
- Toluidine Blue
- Mouth Neoplasms
- Lip Neoplasms
- Precancerous Conditions
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