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Kerala oral cancer visual screening trial (Trivandrum)

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.

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.

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

Phase

Phase 3

Sponsor

Regional Cancer Centre Trivandrum with IARC

Headline 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.

Reported

2005

Enrolled

191873

Outcomes

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In plain words

What these results mean for people, not percentages

191,873 people took part

Oral cancer mortality, tobacco or alcohol users (rate ratio, 3 rounds)primarysurvival endpoint

Visual screening: 0.7.

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

191,873 participants enrolled.

Oral cancer mortality, tobacco or alcohol users (rate ratio, 3 rounds)primary

Download

Rate ratio vs control; 95% CI 0.45-0.95

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Oral cancer mortality, tobacco or alcohol users (rate ratio, 3 rounds)primary	Visual screening	96,517	0.66	—	—	link

Key papers

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rctThe Lancet 2005changed practice

Effect of screening on oral cancer mortality in Kerala, India

Targeted visual screening of tobacco and alcohol users is a cheap, workable way to cut oral cancer deaths in high-incidence countries, and is the basis for India's national oral cancer screening component. Its effect depends on people attending repeatedly and on treatment being available.

Connected

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Pages like this

not linked directly; found by shared links

Evidence strength73/100 · Solid

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
191,873 enrolled+20
Primary endpoint: surrogate (response, pCR, detection)+8
Result: positive+15
No independent replication recorded0

Formula disclosed on the evidence page.

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Sources & links

Data

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