Brief Title
Evaluating Oral Visual Inspection in the Control of Oral Cancer
Official Title
Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
Brief Summary
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for oral cavity cancer using visual inspection on oral cancer mortality.
Detailed Description
The study population consisted of 13 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the remaining 6 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 35 and older, without a personal history of oral cancer. Informed consent was signed by each participant. The intervention arm consisted of 96,517 participants and the control group consisted of 95,356 participants.
Study Type
Interventional
Primary Outcome
Oral Cancer Death Rate
Secondary Outcome
Oral Cavity Cancer Incidence
Condition
Oral Cancer
Intervention
Visual Inspection of Oral Cavity for Precancers and Cancer
Study Arms / Comparison Groups
Control Arm
Description: Standard of Care
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
191873
Start Date
January 1, 1996
Completion Date
December 31, 2014
Primary Completion Date
December 31, 2004
Eligibility Criteria
Inclusion Criteria: Residing in 13 study clusters in Trivandrum City, Kerala Exclusion Criteria: - Diagnosis with oral cancer prior to study - Bedridden subjects - Subjects suffering from open tuberculosis or other debilitating diseases
Gender
All
Ages
35 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Kunnambath Ramadas, MD, PhD, ,
Administrative Informations
NCT ID
NCT04494620
Organization ID
RCC-IEC-Sept 2002
Responsible Party
Sponsor
Study Sponsor
International Agency for Research on Cancer
Collaborators
Regional Cancer Centre Trivandrum
Study Sponsor
Kunnambath Ramadas, MD, PhD, Principal Investigator, Regional Cancer Centre, Trivandrum, India
Verification Date
July 2020