Clinical trial NCT04494620: Evaluating Oral Visual Inspection in the Control of Oral Cancer
Official title: Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Regional Cancer Centre, Trivandrum, India
First posted: 2020-07-31
Enrollment: 191873
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Oral Cancer Death Rate
timeFrame: 15 years
Secondary outcomes:
measure: Oral Cavity Cancer Incidence
timeFrame: 15 years
Other outcomes:
Locations:
Study officials:
affiliation: Regional Cancer Centre, Trivandrum, India
name: Kunnambath Ramadas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Rengaswamy Sankaranarayanan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Thomas G, Anju G, Mathew B. Long term effect of visual screening on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol. 2013 Apr;49(4):314-21. doi: 10.1016/j.oraloncology.2012.11.004. Epub 2012 Dec 21.
citation: Sankaranarayanan R, Ramadas K, Thomas G, Muwonge R, Thara S, Mathew B, Rajan B; Trivandrum Oral Cancer Screening Study Group. Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial. Lancet. 2005 Jun 4-10;365(9475):1927-33. doi: 10.1016/S0140-6736(05)66658-5.
citation: Cheung LC, Ramadas K, Muwonge R, Katki HA, Thomas G, Graubard BI, Basu P, Sankaranarayanan R, Somanathan T, Chaturvedi AK. Risk-Based Selection of Individuals for Oral Cancer Screening. J Clin Oncol. 2021 Feb 20;39(6):663-674. doi: 10.1200/JCO.20.02855. Epub 2021 Jan 15.