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
|
|
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
|
|
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
|
|
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. |