Oral Cancer Clinical Trial
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.
Verified date | July 2009 |
Source | Tata Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Indian Council of Medical Research |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 329 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Hospital | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Hospital | American Cancer Society, Inc., Emory University |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | To estimate the test characteristics of each of the three oral cancer screening techniques. | Six months | No |
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