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CTRI Number  CTRI/2022/06/043030 [Registered on: 06/06/2022] Trial Registered Prospectively
Last Modified On: 05/06/2022
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 in female sex workers  
Scientific Title of Study   Evaluation of smartphone based Artificial Intelligence (AI) - imaging system for screening of cervical cancer in female sex workers - A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maitrayee Sen 
Designation  Associate Professor Department of Obstetrics and Gynecology 
Affiliation  SRM Medical College Hospital and Research Center 
Address  Department of Obstetrics and Gynecology 1st floor SRM Nagar Potheri

Chennai
TAMIL NADU
603 203
India 
Phone  04447432333  
Fax    
Email  dr.maitrayee@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhabrata Pal  
Designation  MedTech Head 
Affiliation  BlockAppsAI Pvt Ltd 
Address  AB5 360 DHI Innovation Bannergatta 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 Bannergatta 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 Bannergatta Road Arekere Bengaluru KARNATAKA 560076 India  
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 Maitrayee Sen  SRM Medical College Hospital and Research Center  Ground floor Room no 41/42 Department of Obstetrics and Gynecology,SRM Medical College Hospital and Research Center, SRM Nagar, Potheri
Chennai
TAMIL NADU 		 04447432333

dr.maitrayee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, , SRM Medical College Hospital and Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1) Female Sex Workers 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 female Sex Workers 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   Data Gathering for secondary outcone happens in the same timelines as that of the primary outcome. In this case its 9 months. 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   07/06/2022 
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
    Response -  Analytic Code

  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 - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NA).

  6. For how long will this data be available start date provided 30-09-2023 and end date provided 30-09-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - na
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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