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Sponsors and Collaborators: |
Tata Memorial Hospital American Cancer Society Emory University |
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Information provided by: | Tata Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00655421 |
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.
Condition | Intervention | Phase |
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Oral Cancer Precancerous Conditions |
Other: Unaided Visual Inspection Device: VelScope Other: Toluidine Blue Assisted Oral Examination |
Phase III |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toludine Blue Application, by Trained Primary Health Care Workers in Mumbai, India. |
Estimated Enrollment: | 300 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Unaided: Experimental
Unaided Visual Inspection of the Oral Cavity
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Other: Unaided Visual Inspection
Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
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VelScope: Experimental
VelScope assisted examination of the oral cavity
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Device: VelScope
Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
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Toluidine: Experimental
Examination of oral cavity after the local application of Toluidine Blue dye
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Other: Toluidine Blue Assisted Oral Examination
Examination of the oral cavity after the local application of Toluidine Blue dye by trained Primary Health Care Worker
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Surendra S Shastri, MD | 91-22-2415-4379 | shastri@vsnl.com |
India, Maharashtra | |
Tata Memorial Hospital | Recruiting |
Mumbai, Maharashtra, India, 400012 | |
Contact: Surendra S Shastri, MD 91-22-2415-4379 shastri@vsnl.com |
Principal Investigator: | Surendra S Shastri, MD | Tata Memorial Hospital |
Responsible Party: | Tata Memorial Hospital, Mumbai, India ( Dr.S.S.Shastri/Professor and Head, Department,Preventive Oncology ) |
Study ID Numbers: | 391 |
Study First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00655421 History of Changes |
Health Authority: | India: Indian Council of Medical Research |
screening oral precancers tobacco users |
VELScope Visual Inspection Toludine Blue |
Lip and Oral Cavity Cancer Mouth Diseases Precancerous Conditions Head and Neck Neoplasms Stomatognathic Diseases Tolonium Chloride |
Heparin Mouth Neoplasms Hemostatics Calcium heparin Oral Cancer |
Mouth Diseases Molecular Mechanisms of Pharmacological Action Precancerous Conditions Coagulants Hematologic Agents Mouth Neoplasms Hemostatics Pharmacologic Actions |
Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Stomatognathic Diseases Heparin Antagonists Tolonium Chloride |