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EFFECT OF SCREENING WITH VISUAL EXAMINATION ON ORAL CANCER MORTALITY IN RATNAGIRI DISTRICT, MAHARASHTRA A CLUSTER-RANDOMIZED CONTROL


Objective

  • To assess the effect of screening using visual examination by trained health workers on oral cancer-related mortality.

  • To assess improvement in survival after a diagnosis of oral cancer.

  • To identify possible etiological factors in a high risk rural population in Ratnagiri district of Maharashtra.


Research Location



About


  • A cluster randomized control trial for oral cancer screening was started in the year 2010 in the Ratnagiri district of Maharashtra state, covering 779 villages.

  • Tobacco prevalence is high in the Ratnagiri district. Out of 3, 2 individuals are tobacco users in the age group 35-65.

  • The inclusion criteria for the screening are individuals between 36-65 years of age and at high risk for developing oral cancer- Chronic users of tobacco such as bidi, cigarette, pan, areca nut, gutkha, etc. (and/or) alcohol.

  • In the first round of the intervention arm, 429 villages have been covered. The total number of high-risk populations is 74,732; out of which, 52,737 (70.6%) attended the screening.

  • The total screen positive individuals in the first round are 1,046 (2.0%). 1 in 50 individuals is screen positive. These 1,046 cases were referred to surgeons. Out of 1046 cases, surgeons verified 955 cases. Out of which, 444 (0.84%) Premalignant disorders (PMDs) were confirmed by surgeons.

  • In the first round of screening, 40 (0.08%) oral cancer cases were diagnosed, out of which 30 (75.0%) individuals received treatment. The first round was completed in 2016.

  • The second round of the intervention arm started in 2014 and is ongoing. In the second round, the eligible population is 64,540; out of which screening has been completed for 49,854 (77.2%) participants and is remaining for 2,883 (5.5%) participants.

  • In the second round, there are 548 (1.1%) screen positive cases, and these cases were referred to the surgeons. 1 in 91 is screen positive. Out of 548 cases, 404 cases were seen by the surgeons. Out of which, 159 (0.32%) PMDs were confirmed by surgeons.

  • In the second round, a total of 31 (0.06%) cancer cases have been diagnosed and out of which 25 (80.6 %) cancer patients have received treatment till now.

  • In terms of stage distribution, there is a stage shift in the cancer case presentation. We have detected 24 (60.0%) late-stage oral cancers cases out of 40 in the first round while in the second round it is 16 (51.6%) out of 31.

  • In the control arm, the first round is completed with 350 villages covered. We have covered 52,431 high-risk populations.

  • The second round of the control arm is ongoing and we have covered 37,179 (70.9%) eligible population. The pending high-risk population is 15,252 (29.1%).

  • The surveillance round for both arms has been started in October 2019 and will be completed by 2023.

  • In the surveillance round, the high-risk population will be followed-up. The status of screen-positive participants and also oral cancer patients will be recorded. Moreover, the PMD cases diagnosed both in the first and second rounds will be examined again to know their status. Apart from these, death cases and verbal autopsies will be recorded and documented.

  • During the project, several group meetings, and school awareness programs have been organized. We have raised awareness regarding tobacco hazards, and the importance of healthy dietary habits and also the importance of early detection of oral cancer in both intervention and control arm.

  • During 2010-2018, we have a total number of 224 oral cancer cases in the intervention arm and 137 in the control arm.

  • The oral cancer cases data collection for the year 2019 and 2020 is in process. There is an under-registration and it will improve during the surveillance round.

  • The programmer of the project has developed three data entry software named Apeksha (for the first round), Pratiksha (for the second round), and Trimurti (for the surveillance round) to speed up the data entry work. The previous software used for this project had several limitations; hence, it was decided to design in-house software.

  • In the intervention arm, we have completed the data entry for 418(97%) out of 429 surveyed villages in the first round; while, 186(46.4%) out of 401 surveyed villages in the second round.

  • Similarly, in the control arm, we have completed data entry for 316(90%) out of 350 surveyed villages in the first round whereas 178 (52.8%) out of 337 villages in the second round.

  • We have also recorded death. During 2010-2019, a total of 21,153 deaths have been recorded. The total number of deaths in the intervention and control arm is 12779 and 8374 respectively. The mean age of death for a male patient is 67 years and for female patients 70 years. 85% of deaths occurred in the House, 11% of deaths occurred in the Hospital & 4% in other places. Cancer is the third leading cause of death both in intervention and control arms.

  • The study was presented at several well-recognized national and international conferences. Dr. Snehal Shah presented a poster on ‘Quality Control in Oral Cancer Screening Trial in Rural India’ at the International Association of Cancer Registries (IACR) 2015 conference organized in Mumbai, India, and won second place in the poster presentation. Also, Dr. Abhijeet Sawant presented a poster on ‘Oral Cancer Screening trial in Rural area of India - A cluster Randomized trial’ at the Global Academic Programs (GAP) 2017 conference held at MD Anderson Centre Houston, TX USA, and won the third place.

  • Several national and international visitors have visited the project site to learn and get trained in the screening program.

  • There are several challenges in running the screening program, however, due to the support of the Director of TMC and administration of the TMH, and the dedication of the staff we could execute the project.

  • The Project progress report was periodically presented to the Director TMC; the suggestions given by him were very productive in implementing the screening project.

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Contribution


Tata Memorial Centre (TMC), Mumbai

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Ratnagiri

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Technical staff from the Centre for Cancer Epidemiology – TMC, Mumbai

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