Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 191,873
- Primary Endpoint
- Oral Cancer Death Rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Oral Cancer Death Rate
Time Frame: 15 years
Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to oral cancer if the patient had histologically or clinically confirmed oral cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of oral cancer treatment.
Secondary Outcomes
- Oral Cavity Cancer Incidence(15 years)