Evaluating Oral Visual Inspection in the Control of Oral Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer

Conditions
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Oral Cancer

Intervention / Treatment
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* Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control group received standard of care while the intervention group received 3 rounds of screening with visual inspection, each 3 years apart. At the 9th year of the study, once significant oral cancer mortality reduction following 3 rounds of screening among the high-risk subjects in the intervention arm was confirmed, the control arm was offered 1 round of screening with visual inspection while the intervention group was offered a 4th round of screening.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Standard of Care | |
| Active Comparator: Intervention Arm<br>Visual Inspection of Oral Cavity for Precancers and Cancer | Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer<br>* Participants were invited for 3 rounds of oral cavity cancer screening, conducted 3-years apart. Screening was conducted by health workers trained to perform visual inspection of the oral mucosa and identify potential precancerous lesions or oral cancer. Lesions found were referred to a weekly clinic for further evaluation by dentists and oncologists with experience in the diagnosis of oral lesions. Oral precancerous lesions were surgically excised whenever possible and those with confirmed oral cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Cancer Death Rate | 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. | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Cavity Cancer Incidence | 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. | 15 years |