FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086420 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective audit of case records 
Study Design  Other 
Public Title of Study   Study of Referrals from a Community-Based Mouth Cancer Awareness and Screening Program in Low-Income Areas of Mumbai 
Scientific Title of Study   Retrospective analysis of referrals from community based oral cancer awareness and screening programme among high risk low-socio economic population of Mumbai 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gauravi Mishra 
Designation  Professor and Physician, Deputy Director 
Affiliation  Tata Memorial Centre 
Address  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012 Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Room No: 230, 2nd Floor, Centre for Cancer Epidemiology ACTREC, Kharghar, Navi Mumbai 410210
Mumbai
MAHARASHTRA
400012
India 
Phone  02224174634  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gauravi Mishra 
Designation  Professor and Physician, Deputy Director 
Affiliation  Tata Memorial Centre 
Address  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012 Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Room No: 230, 2nd Floor, Centre for Cancer Epidemiology ACTREC, Kharghar, Navi Mumbai 410210
Mumbai
MAHARASHTRA
400012
India 
Phone  02224174634  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gauravi Mishra 
Designation  Professor and Physician, Deputy Director 
Affiliation  Tata Memorial Centre 
Address  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012 Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA 400012 India
Room No: 230, 2nd Floor, Centre for Cancer Epidemiology ACTREC, Kharghar, Navi Mumbai 410210
Mumbai
MAHARASHTRA
400012
India 
Phone  02224174634  
Fax    
Email  gauravi2005@yahoo.co.in  
 
Source of Monetary or Material Support  
We are applying for Extramural and Intramural funding support. 
 
Primary Sponsor  
Name  NIL  
Address  NIL  
Type of Sponsor  Other [Intramural and Extramural Funding Support] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gauravi Mishra   Tata Memorial Hospital  3rd Floor Department of Preventive Oncology Tata Memorial Hospital, Parel, Mumbai - 400012 MAHARASHTRA 400012 India
Mumbai
MAHARASHTRA 
02224174634

gauravi2005@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K14||Diseases of oral cavity and salivary glands,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  Participants whose electronic medical records are incomplete.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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).

To determine the correlation between addiction severity scores and the occurrence of potentially malignant or malignant oral lesions.

To analyze the sociodemographic factors associated with the prevalence of oral lesions among tobacco users. 
3 months 
 
Target Sample Size   Total Sample Size="1600"
Sample Size from India="1600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The National Programme for Prevention and Control of NCDs (NP-NCD) 2023-2030 outlines a comprehensive framework for the prevention and control of Non-Communicable Diseases (NCDs) at the national and sub national levels. The guidelines focus on integrating interventions of five common NCDs including cancers into existing healthcare systems, primarily focusing on early detection, prevention, treatment, and management. It also emphasizes on strengthening public health infrastructure, integrating cancer screening services, and promoting awareness campaigns to reduce cancer risk factors like tobacco use, alcohol consumption, and unhealthy diets. The guidelines also encourage the implementation of community-based screening programs for common cancers, including cervical, breast, and oral cancers, along with the development of cancer registries to monitor incidence and outcomes.

Globally, the burden of Non-Communicable Diseases (NCDs) is very high with 41 million deaths annually. Cancers ranks second among NCDs with 9.3 million deaths annually. As per the WHO-NCD India profile -2018, NCDs account for 63% of overall deaths in the country of which 9% deaths are because of cancer. Lip and oral cavity cancers are the 16th most prevalent cancer worldwide, with 389,846 new cases, and the second most common cancer in India, with 143,759 cases. It ranks first among cancers affecting males. Tobacco use remains the most significant global public health challenge. National Family Health Survey phase-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 of oral cavity cancers usually in low socioeconomic settings is due to increased use of tobacco in this population and lack of awareness. The high incidence rates of oral cancers in India are attributed to various risk factors, predominantly tobacco use, which is a major contributor to the development of oral 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 highest number of tobacco users and together account for more than 1/3rd (38%) of tobacco users in India. Maharashtra has 26.6% of tobacco users with 24.4% of adults using tobacco in smokeless forms. A 2004 International Agency for Research on Cancer (IARC) review committee based on epidemiologic and laboratory studies concluded that smokeless tobacco use is carcinogenic to humans and attributed to oral cancers and pancreatic cancers. Studies indicate that smokeless tobacco products are particularly prevalent in India, with extensive evidence linking them to oral cancer through the presence of carcinogenic nitrosamines. With this background and with our past experience of implementation of tobacco cessation programmes at work place and in community, we initiated a service programme for awareness and screening of oral cavity cancers among the low socioeconomic settings of Mumbai.

Details of Service Programme and its outcomes:

Department of Preventive Oncology, Tata Memorial Hospital (TMH) with funding support from Watumull Sanatorium Trust had initiated a service programme titled “Oral Cancer Screening Programme among High Risk Population Residing in Low Socio-Economic Settings in Mumbai, Maharashtra: An Organized Service Programme”. The implementation of this project was in coherence with the operational guidelines of National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD) 2023-2030 programme. The project was initiated in August 2022 and was completed in duration 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. This project aimed towards creating awareness about hazards of smoking as well as smokeless tobacco and alcohol use among participants and identifying risk factor exposure and screening participants using tobacco &/or alcohol for oral cavity pre-cancers and cancers and ultimately assisting them for diagnostic investigations and further management.

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

The proposed project would be conducted as a retrospective audit of case records of the participants recruited and screened positive during implementation of the Oral Cancer Awareness and Screening Programme. All case records of screen positives registered in Preventive Oncology Screening Clinic will be identified and retrieved through the central Electronic Medical Record (EMR) system of the hospital. To protect the patients’ identity, Unique Identification Code will be generated for all case records to remove all patient identifiers. The de-identified records will then use to capture data as per the study objective on a standardized structured data format.

 
Close