NCT04494620

Evaluating Oral Visual Inspection in the Control of Oral Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 191,873 (actual)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Visual Inspection of Oral Cavity for Precancers and Cancer	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.

Timeline

• Start date: 1996-01-01
• Primary completion: 2004-12-31
• Completion: 2014-12-31
• First posted: 2020-07-31
• Last updated: 2020-07-31