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CTRI Number  CTRI/2022/05/042719 [Registered on: 23/05/2022] Trial Registered Prospectively
Last Modified On: 19/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Diagnostic Accuracy Study 
Study Design  Other 
Public Title of Study   PredAID-CERVIA: AI based Cervical Cancer Screening  
Scientific Title of Study   Evaluation of a smartphone-based AI-imaging system for screening of cervical cancer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuja Vivek Bhalerao 
Designation  Professor & HOD Gynaecology & Obstetiecs 
Affiliation  NKPSIMS & Lata mangeshkar hospital 
Address  NKPSIMS & Lata mangeshkar hospital, Gynaecology & Obstetiecs department, 5th floor, Hingna Road Digdoh hills police nagar Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone    
Fax    
Email  anuja_bhalerao@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhabrata Pal 
Designation  MedTech Head 
Affiliation  BlockAppsAI Pvt Ltd 
Address  AB5 360 DHI Innovation Bannergattha Road Arekere Bengaluru

Bangalore
KARNATAKA
560076
India 
Phone    
Fax    
Email  shubho@blockappsai.com  
 
Details of Contact Person
Public Query  
Name  Sridhar Yilapavanam 
Designation  CEO 
Affiliation  BlockAppsAI Pvt.Ltd 
Address  AB5 360 DHI Innovation Bannergattha Road Arekere Bengaluru

Bangalore
KARNATAKA
560076
India 
Phone    
Fax    
Email  sri@blockappsai.com  
 
Source of Monetary or Material Support  
BlockAPpsAI PVt. Ltd. 
 
Primary Sponsor  
Name  BlockAppsAI Pvt Ltd 
Address  AB5 360 DHI Innovation Bannergattha Road Arekere Bengaluru 
Type of Sponsor  Other [Private Limited Company in MedTech] 
 
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 Anuja Bhalerao  NKPSIMS & Lata mangeshkar hospital  NKPSIMS & Lata mangeshkar hospital,Gynaecology & Obstetiecs department, 5th floor, Hingna Road Digdoh hills police nagar Nagpur
Nagpur
MAHARASHTRA 		 9823680572

anuja_bhalerao@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, NKP Salve Instuite of Medical Sciences and research and LMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1) Women aged between 25 and 65 years of age, inclusive. 2) Participants should have a history of sexual activity  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1)Women aged between 25 and 65 years of age, inclusive.
2)Participants should have a history of sexual activity.
 
 
ExclusionCriteria 
Details  1)Menstruating women
2)Pregnant women women who have had childbirth with 6 weeks prior to the date of test
3)Women who have had hysterectomy
4)Women who have vaginal infections, discharge etc. at the time of the test
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Specificity, sensitivity, PPV and NPV of prediction of VIA classes, namely, "Positive", "Negative" or "Suspicious for Cancer" by PredAID-CerVIA and a group of experienced gynecologists (Human Expert Group), taking a combination of conventional cytology (Pap smear) and physicians verdict as reference.  9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome: Measure of the subjects experience, and opinion of the VIA procedure based on the following criteria – level of comfort, level of comfort with smartphone camera-based image acquisition the likelihood of repeating the test on a yearly two-yearly or five-yearly basis  Same time point as the primary outcome 
 
Target Sample Size   Total Sample Size="1300"
Sample Size from India="1300" 
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)   25/05/2022 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 18-01-2023 and end date provided 18-01-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NI:
Brief Summary  

Cervical cancer mortality can be largely prevented by early detection of the disease through screening programs. Countries that have properly implemented Pap-smear or HPV DNA tests as screening modalities have seen a significant drop in cervical cancer-related mortality. However, Pap-smear or HPV DNA testing is not suitable for developing countries such as India. Alternatives, such as Visual Inspection by Acetic Acid (VIA) and Visual Inspection by Lugol’s Iodine (VILI) are highly suited to low-resource settings but have significant barriers to scaling – due to variability inherent in manual assessment. In this scenario, technologies such as Artificial Intelligence, Computer Vision, and mobile photography offer the possibility of creating robust, low-cost, scalable, and sustainable solutions for the mass screening of cervical cancer. The proposed study seeks to evaluate the sensitivity, specificity, Positive Predictive Value, and Negative Predictive Value of PredAID-CVIA – a smartphone-based, AI-solution for assessment of VIA for women in Tertiary care center at LMH Nagpur, and compare its performance against human experts.

 
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