Evaluating Oral Visual Inspection in the Control of Oral Cancer

Not Applicable

Completed

• Conditions: Oral Cancer

• Registration Number: NCT04494620
• Lead Sponsor: International Agency for Research on 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 Timeline

• Study Start: 1996-01-01
• Primary Completion: 2004-12-31
• Study Completion: 2014-12-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-28
• Last Update Submitted: 2020-07-28
• Study First Posted: 2020-07-31
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191873

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral Cancer Death Rate	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 Outcome Measures

Name	Time	Method
Oral Cavity Cancer Incidence	15 years	Information on incident oral cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating oral cancer patients. Collection of information was blinded to study group assignment of cases. The staging of oral cancers was done according to the UICC TNM staging system.