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CTRI Number  CTRI/2025/01/078863 [Registered on: 16/01/2025] Trial Registered Prospectively
Last Modified On: 21/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Testing the accuracy and reliability of Berry.care, an AI based Oral Cancer Screening tool in community settings 
Scientific Title of Study   POCTRN Point of Care Technologies for Nutrition Infection and Cancer for Global Health PORTENT Study AI based Oral Cancer Screening  
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 Hari Menon 
Designation  Professor of Haematology & Head of Medical Oncology 
Affiliation  St Johns Medical College Hospital 
Address  Department of Medical Oncology, St Johns Medical College Hospital, St Johns National Academy of Health Sciences, Sarjapur Road

Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax    
Email  hari.menon@stjohns.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Verghese Thomas 
Designation  Assistant Professor - Research 
Affiliation  St Johns Research Institute 
Address  Division of Medical Informatics, St Johns Research Institute, 100 Ft Road, Koramangala

Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax    
Email  verghese.t@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Ryan Fernandez 
Designation  Assistant Professor and RDGO 
Affiliation  St Johns Research Institute 
Address  Division of Medical Informatics, St Johns Research Institute, 100 Ft Road, Koramangala

Bangalore
KARNATAKA
560034
India 
Phone  08049467000  
Fax    
Email  ryan@sjri.res.in  
 
Source of Monetary or Material Support  
National Institutes of Health (NIH) National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 
Primary Sponsor  
Name  NIH National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
Address  9000 Rockville Pike Building 31, Room 1C14 Bethesda, MD 20892, 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Menon  St Johns Medical College Hospital   Department of Medical Oncology, St Johns Medical College Hospital, St Johns National Academy of Health Sciences, Sarjapur Road
Bangalore
KARNATAKA 		 08049467000

hari.menon@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Institutional Ethics Committee, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adult volunteers attending dental health camps 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Onsite Oral cancer screening by trained dentist  A trained dentist will do a physical examination on the participants to screen for oral potentially malignant disorders during oral health camps. Each patient will undergo history taking and oral cavity examination by the dentist which will take approximately 10 minutes. The medications will be prescribed and referral provided as per the dentist opinion. The entire duration of the study is 1 year.  
Intervention  Oral cancer screening by community health workers using Berry.care mobile app  Berry.care, an AI based oral cancer screening mobile app will be used by an onsite community health care worker (CHW) to screen for oral potentially malignant disorders among participants attending oral health camps. Each participant will undergo one-time cancer screening using Berry.care and it will take about 5 minutes. During the screening, the CHW will take 10 photos of the participants oral cavity and submit them to the Berry.care AI tool for identification of Oral potentially malignant disorders. The total duration of the study is 1 year 
Comparator Agent  Remote evaluation by panel of clinical experts examining the images of the oral cavity captured by the Berry.care mobile app  A panel of clinical experts comprising of 3 medical oncologists will review the images of the oral cavity from each patient and identify any oral potentially malignant disorders without accessing the AI based screening results. They will also have access to information of patient risk factor for oral cancer that is collected during the camp. They will not be attending the oral health camps and so will be performing screening remotely from the participants. The total duration of the study is 1 year. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Male and female participants from factory settings who attend dental camps for screening in Bangalore (Karnataka) and krishnagiri (Tamil Nadu) districts  
 
ExclusionCriteria 
Details  1.Individuals with previously diagnosed and treated oral cancer will be excluded to focus on the effectiveness of the app in supporting screening processes for premalignant or early cancerous lesions.

2.Persons who fail the trismus test (unable to open their mouth sufficiently to insert 3 fingers), because appropriate images cannot be captured.

3.Persons with any major trauma / medical condition / major surgeries / facial nerve palsies/ deformity or any other condition affecting acquisition of images from the oral cavity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Validity (sensitivity and specificity) of the Berry.care app in identifying oral potentially malignant disorders  Individuals will undergo oral cancer screening once at the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
Usability of the berry.care app - metrics of user satisfaction, ease of use, and time on task as well as insights for design improvements to the berry.care app will be obtained from usability tests with end users  Healthcare workers will perform usability tests on the berry.care app once at the time of recruitment.  
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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)   03/03/2025 
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="1"
Months="0"
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 proposed research aims to evaluate the effectiveness of an AI-based tool for early detection of oral cancer, specifically focusing on its use in both rural and urban healthcare settings. This research is driven by the urgent need for improved screening methods, particularly in under served regions, where late-stage oral cancer diagnosis is common due to limited access to healthcare facilities. The main objectives include validating the AI tool’s accuracy in detecting precancerous lesions and early signs of oral cancer using smartphone-captured images, assessing its feasibility for integration into existing healthcare systems, and determining its potential to enhance early detection rates. The importance of this work lies in its alignment with national health priorities, particularly the need to address rising cancer rates in India and expand access to effective, non-invasive diagnostic tools. The study’s outcomes will contribute to advancing affordable, scalable solutions for oral cancer screening in India.  
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