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CTRI Number  CTRI/2019/11/022167 [Registered on: 27/11/2019] Trial Registered Prospectively
Last Modified On: 01/09/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Mobile Oral Cancer Screening In Limited Resource Setting 
Scientific Title of Study   Low- Cost Mobile Oral Cancer Screening For Low Resource Setting  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveen BN 
Designation  Vice Principal, Professor and Head 
Affiliation  KLE Society’s Institute of Dental Sciences 
Address  Dr Praveen BN Vice Principal, Professor and Head Department of Oral Medicine and Radiology KLE Society’s Institute of Dental Sciences #20, Yeshwanthpur suburb, Bengaluru

Bangalore
KARNATAKA
560022
India 
Phone  919845136960  
Fax    
Email  praveen.birur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen BN 
Designation  Vice Principal, Professor and Head 
Affiliation  KLE Society’s Institute of Dental Sciences 
Address  Dr Praveen BN Vice Principal, Professor and Head Department of Oral Medicine and Radiology KLE Society’s Institute of Dental Sciences #20, Yeshwanthpur suburb, Bengaluru


KARNATAKA
560022
India 
Phone  919845136960  
Fax    
Email  praveen.birur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Keerthi G 
Designation  Senior Lecturer 
Affiliation  KLE Society’s Institute of Dental Sciences 
Address  Dr Keerthi G Senior lecturer Department of Oral Medicine and Radiology KLE Society’s Institute of Dental Sciences #20, Yeshwanthpur suburb, Bengaluru

Bangalore
KARNATAKA
560022
India 
Phone  918861130965  
Fax    
Email  keerthi_g80@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Health, USA 4UH3CA239682-03 
 
Primary Sponsor  
Name  National Institute of Health 
Address  Department of Health and Human Services National Institutes of Health NATIONAL CANCER INSTITUTE USA 
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 Rohan Michael Ramesh  Christian Institute of Health Sciences and Research  Ground floor, Department of community medicine, 4th Mile, P.B No 31, P.O ARTC, Nagaland 797115.
Dimapur
NAGALAND 		 917085055422

roan.ramesh@gmail.com 
Dr Praveen BN  KLE Society’s Institute of Dental Sciences  Room No. 2, Department of Oral Medicine and Radiology, KLE Society’s Institute of Dental Sciences #20, Yeshwanthpur suburb, Bengaluru
Bangalore
KARNATAKA 		 919845136960

praveen.birur@gmail.com 
Dr Vijay Pillai  Mazumdar Shaw Medical Center  room no. 40, 6th floor, No. 258 / A, Head and neck oncology services, Bommasandra Industrial Area Anekal Taluk, Bangalore – 560099
Bangalore
KARNATAKA 		 919449061932

drvijaypillai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Christian Institute of Health Sciences and research  Approved 
KLE Society’s Institute of Dental Sciences, Bengaluru   Approved 
Narayana Health Medical ethics committee, Bengaluru   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: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1. Clinically Suspicious oral Lesions (Including leukoplakia, erythroplakia, Lichen planus, benign lesions- epithelial tumors, ulcers, vesiculobullous lesions like pemphigus vulgaris)
2. History of previously treated OSCC, with no current evidence of cancer recurrence at least for 6 months after cessation of treatment.
3. Presence of recently diagnosed untreated OSCC or a precancerous lesion
4. Individuals positive for tobacco habit
 
 
ExclusionCriteria 
Details  1. Less than or equal to 18 years of age
2. Currently undergoing treatment for malignancy
3. Pregnancy
4. Under treatment for tuberculosis or suffering from any acute illness
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Identification of Oral precancer and cancer by Frontline healthcare providers using point of care diagnostic tool.
2. To develop an AI based diagnosis 		 Interim analysis performed at the end of 12months to assess FHPs for identification of oral precancer and cancer using point of care diagnostic tool
At the end of two and half years to develop AI based algorithm  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the agreement between FHPs/ Onsite specialist/ Remote specialist/ AI algorithm
To evaluate the agreement between the remote diagnosis/ Biopsy 		 3 years 
 
Target Sample Size   Total Sample Size="6400"
Sample Size from India="6400" 
Final Enrollment numbers achieved (Total)= "5025"
Final Enrollment numbers achieved (India)="5025" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2019 
Date of Study Completion (India) 31/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This project is a multicentric study, in India at three sub-centers. The aim of this research is to empower the health care workers in rural India to identify oral & pharyngeal lesions with a mobile phone. The device acts as “Point of Care” diagnosis for early detection of Oral Cancer and approach creates an opportunity to connect specialists to rural population, facilitates timely referrals and follow up.  Study aimed at Field validation of mobile intraoral system for Oral cancer in LMIC settings. 
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