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CTRI Number  CTRI/2023/09/057181 [Registered on: 01/09/2023] Trial Registered Prospectively
Last Modified On: 31/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Mobile phone in oral cancer detection in rural settings 
Scientific Title of Study   Mobile oral cancer screening system for low-resource settings 
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 Praveen Birur N 
Designation  Vice-principal, Professor and Head 
Affiliation  KLE Societys Institute of Dental Sciences 
Address  Room no 2, ground floor,Department of Oral Medicine and Radiology, KLE Society Institute of Dental Sciences,no. 20, Yeshwanthpur suburb, Tumkur road, Bengaluru.

Bangalore
KARNATAKA
560022
India 
Phone  09845136960  
Fax    
Email  praveen.birur@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praveen Birur N 
Designation  Vice-principal, Professor and Head 
Affiliation  KLE Societys Institute of Dental Sciences 
Address  Room no 2, ground floor,Department of Oral Medicine and Radiology, KLE Society Institute of Dental Sciences,no. 20, Yeshwanthpur suburb, Tumkur road, Bengaluru.

Bangalore
KARNATAKA
560022
India 
Phone  09845136960  
Fax    
Email  praveen.birur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amritha Suresh 
Designation  Operational Head, Principal Investigator  
Affiliation  Mazumdar Shaw center for translational research 
Address  Room no DSRG-5, 8th floor, Mazumdar shaw medical foundation, Mazumdar Shaw Center for translational research, Narayana Health, Bommasandra Industrial area, Bengaluru.

Bangalore
KARNATAKA
560099
India 
Phone  8105114670  
Fax    
Email  amritha.suresh@gmail.com  
 
Source of Monetary or Material Support  
National Institutes of Health, United States 
 
Primary Sponsor  
Name  National Institutes of Health, United States 
Address  9000 Rockville Pike, Bethesda, Maryland 20892  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Praveen Birur N  KLE Societys Institute of Dental Sciences  Room number-2, Department of Oral Medicine and Radiology, Yeshwanthpur Suburb, Tumkur Road, Bengaluru
Bangalore
KARNATAKA 
09845136960

praveen.birur@gmail.com 
Dr Vijay Pillai  Mazumdar Shaw Medical Center  Consultant, Room No.39, 6th floor, B block, Department of Head and Neck Oncology No. 258 / A, Bommasandra Industrial Area Anekal Taluk, Bangalore – 560099
Bangalore
KARNATAKA 
09449061932

drvijaypillai@gmail.com 
Dr Amritha Suresh  Mazumdar Shaw Medical Foundation  Room- Admin block Primer, Department of Integrated Head and neck oncology program, no.258/A, Hosur Road, Bommasandra, Bengaluru
Bangalore
KARNATAKA 
8105114670

amritha.suresh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
KLE Societys institute of Dental Sciences  Approved 
Narayana Health Medical Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, (2) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1. ALl individuals above 18 years and having Clinically suspicious oral lesions which are indicated for biopsy. 
 
ExclusionCriteria 
Details  1. Individuals less than 18 years
2. Pregnant women
3. Individuals currently undergoing treatment for malignancy
4. Individuals having acute illness or undergoing treatment for tuberculosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proposed dual mode intraoral imaging system will deliver new & imperatively
needed capabilities to the end users in low resource setting. This artificial intelligence
integrated system will: (1) detect suspicious regions with high sensitivity & specificity;
(2) enable automatic, accurate, & objective in situ diagnosis; & in screening program
settings or nodal center settings, the device will triage suspicious or non-suspicious
lesions.
 
1. Optimize a mobile imaging system for low-resource setting in year 1
2. Develop mobile based deep learning image classification in year 1
3. Validate the clinical usefulness of the mobile imaging system in year 2 
 
Secondary Outcome  
Outcome  TimePoints 
Final outcome of the study is to achieve Diagnostic sensitivity & specificity of: 1) 95
% for distinguishing OSCC from healthy sites; (2) 90% for distinguishing OPML from
healthy tissues; and (3) 85% for distinguishing non-neoplastic lesion from healthy, oral cancer, or OPML tissues. 
The diagnostic accuracy, sensitivity & specificity will be achieved at the end of second year 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   18/09/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Oral cancer is the most common cancer in India, accounting for 40% of all cancers overall and accounting for one-third of the world burden. The poor survival rate in India is mainly due to late diagnosis and the resultant progression of disease to an advanced stage at diagnosis. Therefore, there exists an urgent need for low-cost, easy to use imaging device that enables oral cancer screening and triage patients in Low- Resource Settings (LRS). The major goal of the study is to validate a low cost dual mode mobile intraoral imaging system for oral cancer detection in LRS. This project provides early detection of oral lesions and timely patient referral to specialists can avoid disease progression, reduce morbidity and mortality. The successful demonstration of this mobile dual mode intra-oral imaging screening system will lead to a sustainable solution for early detection of oral cancers in community settings, eventually improving oral cancer detection rates, treatment outcomes, and quality of life of patients in LRS.


The project team has developed mobile imaging platform that specifically addresses critical barriers to improve oral cancer screening and management in LRS. The mobile imaging platform consists of a smart phone, mobile App, intraoral imaging probe, cloud computing, and web application. More than 5,000 patients in three locations in India (cancer center, dental school, and remote region) were screened to demonstrate the performance. Remote specialists using the mobile oral cancer screening data achieved diagnostic sensitivities and specificities of 92% and 85% respectively vs. the standard-of-care (SOC). A convolutional neural network (CNN) based deep learning method for classifying oral images and achieved sensitivity of 87% and specificity of 87%, for delineating oral cancer and pre-cancer lesions. The aim of this research

is to modify the dual mode mobile imaging platform (prototype) for real time clinical use in low resource setting.

 
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