Evaluating Oral Visual Inspection in the Control of Oral Cancer

International Agency for Research on Cancer

Status: Completed

Conditions: Oral Cancer

Treatments: Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT04494620

RCC-IEC-Sept 2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 191,873 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191,873 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Standard of Care

Intervention Arm

Active Comparator group

Description:

Visual Inspection of Oral Cavity for Precancers and Cancer

Treatment:

Diagnostic Test: Visual Inspection of Oral Cavity for Precancers and Cancer