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
|
|
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
|
|
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. |