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Study of Referrals from a Community-Based Mouth Cancer Awareness and Screening Program in Low-Income Areas of Mumbai

Not yet recruiting
Conditions
Diseases of oral cavity and salivary glands,
Registration Number
CTRI/2025/05/086420
Brief Summary

TheNational Programme for Prevention and Control of NCDs (NP-NCD) 2023-2030outlines a comprehensive framework for the prevention and control ofNon-Communicable Diseases (NCDs) at the national and sub national levels. The guidelinesfocus on integrating interventions of five common NCDs including cancers intoexisting healthcare systems, primarily focusing on early detection, prevention,treatment, and management. It also emphasizes on strengthening public healthinfrastructure, integrating cancer screening services, and promoting awarenesscampaigns to reduce cancer risk factors like tobacco use, alcohol consumption,and unhealthy diets. The guidelines also encourage the implementation ofcommunity-based screening programs for common cancers, including cervical, breast,and oral cancers, along with the development of cancer registries to monitorincidence and outcomes.

Globally,the burden of Non-Communicable Diseases (NCDs) is very high with 41 milliondeaths annually. Cancers ranks second among NCDs with 9.3 million deathsannually. As per the WHO-NCD India profile -2018, NCDs account for 63% ofoverall deaths in the country of which 9% deaths are because of cancer. Lip andoral cavity cancers are the 16th most prevalent cancer worldwide, with 389,846new cases, and the second most common cancer in India, with 143,759 cases. Itranks first among cancers affecting males. Tobacco use remains the mostsignificant global public health challenge. National Family Health Surveyphase-I was conducted in 2019-20. It reports tobacco use in all states of India.The prevalence of tobacco use is higher in rural area. The high incidence oforal cavity cancers usually in low socioeconomic settings is due to increaseduse of tobacco in this population and lack of awareness. The high incidencerates of oral cancers in India are attributed to various risk factors,predominantly tobacco use, which is a major contributor to the development oforal cancers. Most commonly used smokeless product in India are, khaini, gutkha,betel quid with tobacco and zarda etc. Smoking forms of tobacco used are bidi,cigarette and hookah. Maharashtra, West Bengal and Uttar Pradesh have highestnumber of tobacco users and together account for more than 1/3rd(38%) of tobacco users in India. Maharashtra has 26.6% of tobacco users with24.4% of adults using tobacco in smokeless forms. A 2004 International Agencyfor Research on Cancer (IARC) review committee based on epidemiologic andlaboratory studies concluded that smokeless tobacco use is carcinogenic tohumans and attributed to oral cancers and pancreatic cancers. Studies indicatethat smokeless tobacco products are particularly prevalent in India, withextensive evidence linking them to oral cancer through the presence of carcinogenicnitrosamines. With this background and with our past experience of implementationof tobacco cessation programmes at work place and in community, we initiated aservice programme for awareness and screening of oral cavity cancers among thelow socioeconomic settings of Mumbai.

**Details of Service Programme and its outcomes:**

Department of Preventive Oncology,Tata Memorial Hospital (TMH) with funding support from Watumull SanatoriumTrust had initiated a service programme titled “Oral Cancer Screening Programmeamong High Risk Population Residing in Low Socio-Economic Settings in Mumbai,Maharashtra: An Organized Service Programme”. The implementation of thisproject was in coherence with the operational guidelines of National Programmefor Prevention and Control of Non-Communicable Diseases (NP-NCD) 2023-2030programme. The project was initiated in August 2022 and was completed induration of four years. It was implemented in slums of 25 BMC wards in Mumbai,involving a total of 25,000 beneficiaries, around 1000 from each Ward. Thisproject aimed towards creating awareness about hazards of smoking as well assmokeless tobacco and alcohol use among participants and identifying riskfactor exposure and screening participants using tobacco &/or alcohol fororal cavity pre-cancers and cancers and ultimately assisting them fordiagnostic investigations and further management.

Retrospective analyses conducted indifferent regions of India have concluded that different harmful tobacco habitsare correlated with prevalence of oral cavity cancer. The retrospectiveanalysis shows that close to 30-40% Oral Squamous Cell Carcinoma cases arelinked to tobacco use, indicating the need for early detection strategies,effective awareness and screening programmes to mitigate the disease impact.

The proposed project would beconducted as a retrospective audit of case records of the participantsrecruited and screened positive during implementation of the Oral CancerAwareness and Screening Programme. All case records of screen positivesregistered in Preventive Oncology Screening Clinic will be identified andretrieved through the central Electronic Medical Record (EMR) system of thehospital. To protect the patients’ identity, Unique Identification Code will begenerated for all case records to remove all patient identifiers. Thede-identified records will then use to capture data as per the study objectiveon a standardized structured data format.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
1600
Inclusion Criteria

Referred participants of oral cancer screening programme who have attended Screening Clinic of Department of Preventive Oncology, and whose electronic medical records are fully comprehensive as per the standard operating procedure of Tata Memorial Hospital.

Exclusion Criteria

Participants whose electronic medical records are incomplete.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Prevalence of clinically detected potentially malignant and malignant oral lesions among tobacco users referred from a community-based oral cancer awareness and screening program.Prevalence of clinically As this is a retrospective analysis based on records from a community-based oral cancer screening program, there are no predefined time points such as baseline or follow-up at specific intervals. The outcomes (referrals) are assessed from existing data collected during and after the initial screening period. Therefore, time points are not applicable in the traditional prospective sense.
Secondary Outcome Measures
NameTimeMethod
To assess the compliance of participants to initial screening, referral advice, and treatment initiation.To evaluate the association between the presence of oral lesions and the pattern of tobacco use (type, duration, and frequency).

Trial Locations

Locations (1)

Tata Memorial Hospital

🇮🇳

Mumbai, MAHARASHTRA, India

Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Gauravi Mishra
Principal investigator
02224174634
gauravi2005@yahoo.co.in

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