Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Cancer Screening in Mumbai, India by Primary Health Care Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00655421
Recruitment Status : Unknown
Verified July 2009 by Tata Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 9, 2008
Last Update Posted : July 3, 2009
Sponsor:
Collaborators:
American Cancer Society, Inc.
Emory University
Information provided by:
Tata Memorial Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2008
First Posted Date  ICMJE April 9, 2008
Last Update Posted Date July 3, 2009
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00655421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
To estimate the test characteristics of each of the three oral cancer screening techniques. [ Time Frame: Six months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Cancer Screening in Mumbai, India by Primary Health Care Workers
Official Title  ICMJE 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.
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Condition  ICMJE
  • Oral Cancer
  • Precancerous Conditions
Intervention  ICMJE
  • Other: Unaided Visual Inspection
    Simple unaided visual inspection of the oral cavity with a bright white light source by trained Primary Health Care Worker
  • Device: VelScope
    Examination of the oral cavity through a VelScope by trained Primary Health Care Worker
  • 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
Study Arms  ICMJE
  • Experimental: Unaided
    Unaided Visual Inspection of the Oral Cavity
    Intervention: Other: Unaided Visual Inspection
  • Experimental: VelScope
    VelScope assisted examination of the oral cavity
    Intervention: Device: VelScope
  • Experimental: Toluidine
    Examination of oral cavity after the local application of Toluidine Blue dye
    Intervention: Other: Toluidine Blue Assisted Oral Examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: July 2, 2009)
329
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)
300
Estimated Study Completion Date  ICMJE September 2009
Estimated Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655421
Other Study ID Numbers  ICMJE 391
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.S.S.Shastri/Professor and Head, Department,Preventive Oncology, Tata Memorial Hospital, Mumbai, India
Study Sponsor  ICMJE Tata Memorial Hospital
Collaborators  ICMJE
  • American Cancer Society, Inc.
  • Emory University
Investigators  ICMJE
Principal Investigator: Surendra S Shastri, MD Tata Memorial Hospital
PRS Account Tata Memorial Hospital
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP