# Kerala oral cancer visual screening trial (Trivandrum)

Source: https://onco.cc/trials/kerala-oral-screening/  
OnCo record `kerala-oral-screening` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Trained health workers looking inside the mouths of tobacco and alcohol users in Kerala cut oral cancer deaths by a third, and by four-fifths in those who came to every screening round.

## Summary

96,517 people in seven intervention clusters and 95,356 in six control clusters were enrolled. After three rounds there were 77 oral cancer deaths in the intervention arm versus 87 in controls (mortality rate ratio 0.79; 95% CI 0.51-1.22 overall), with a significant reduction among tobacco or alcohol users (0.66; 95% CI 0.45-0.95), and 0.57 in male users. At 15 years, after four rounds, oral cancer mortality was 24% lower in tobacco or alcohol users in the intervention arm (95% CI 3-40%) and 81% lower (69-89%) in users who attended all four rounds, with a 38% fall in incidence in that group. It remains the only randomised evidence that oral cancer screening saves lives and underpins India's national screening programme for oral cancer.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Phase: 3
- Setting: Cluster-randomised trial in 13 clusters of Trivandrum district: three (later four) rounds of oral visual inspection by trained health workers vs usual care in adults aged 35 and over
- Sponsor: Regional Cancer Centre Trivandrum with IARC
- Enrolled: 191873
- Result: Oral cancer mortality rate ratio 0.66 in tobacco/alcohol users after 3 rounds; 81% reduction in users who attended all 4 rounds at 15 years.
- Outcomes: Oral cancer mortality, tobacco or alcohol users (rate ratio, 3 rounds): Visual screening 0.66

## Sources

- Sankaranarayanan et al., Lancet 2005: https://doi.org/10.1016/S0140-6736(05)66658-5
- 15-year follow-up, Oral Oncology 2013: https://doi.org/10.1016/j.oraloncology.2012.11.004

## Connected records

- cancers: [Buccal mucosa and gingivobuccal cancer (oral cancer in India)](https://onco.cc/cancers/buccal-mucosa-cancer/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Oral cavity cancer (mouth and tongue)](https://onco.cc/cancers/oral-cavity-cancer/)
- technologies: [Chemoprevention & risk-reducing surgery](https://onco.cc/technologies/chemoprevention/), [Global oncology and access in low- and middle-income countries](https://onco.cc/technologies/global-oncology-access/), [Oral cancer visual screening](https://onco.cc/technologies/oral-visual-screening/)
- institutions: [International Agency for Research on Cancer (IARC / WHO)](https://onco.cc/institutions/iarc/)
- people: [Rengaswamy Sankaranarayanan](https://onco.cc/people/sankaranarayanan-rengaswamy/)
- bottlenecks: [Prevention we already have is not deployed](https://onco.cc/bottlenecks/b-prevention-adoption/), [The hardest cancers are found late](https://onco.cc/bottlenecks/b-early-detection/)
- key papers: [Effect of screening on oral cancer mortality in Kerala, India](https://onco.cc/key-papers/paper-sankaranarayanan-oral-screening-lancet-2005/)
- terms: [Cluster-randomised trial](https://onco.cc/terms/cluster-randomised-trial/), [Ethics review (IRB, research ethics committee)](https://onco.cc/terms/ethics-review/), [Informed consent](https://onco.cc/terms/informed-consent/), [Pragmatic trial](https://onco.cc/terms/pragmatic-trial/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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