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CTRI Number  CTRI/2019/12/022368 [Registered on: 13/12/2019] Trial Registered Prospectively
Last Modified On: 12/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Screening 
Study Design  Single Arm Study 
Public Title of Study   Comparative performance evaluation of Artificial Intelligence (AI) based visual inspection test (AI_VIA) with Primary Health Worker administered VIA (PHW_VIA), HPV DNA test and cervical cytology to detect cervical pre-cancer lesions. 
Scientific Title of Study   Comparative performance evaluation of Artificial Intelligence (AI) based visual inspection test (AI_VIA) with Primary Health Worker administered VIA (PHW_VIA), HPV DNA test and cervical cytology to detect cervical pre-cancer lesions. 
Trial Acronym  AI_VIA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharmila Pimple 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive oncology 3rd floor Service block Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939   
Fax    
Email  drsharmilapatil@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharmila Pimple 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive oncology 3rd floor Service block Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939   
Fax    
Email  drsharmilapatil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharmila Pimple 
Designation  Professor and Physician 
Affiliation  Tata Memorial Hospital 
Address  Department of Preventive oncology 3rd floor Service block Tata Memorial Hospital Dr Ernest Borges road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9223207939   
Fax    
Email  drsharmilapatil@yahoo.com  
 
Source of Monetary or Material Support  
Periwinkle Technologies Pvt Ltd 
 
Primary Sponsor  
Name  Periwinkle Technologies Pvt Ltd 
Address  Venture Center, 100, Ncl Innovation Park, Dr. Homi Bhabha Road, Pashan, Pune, Maharashtra 411008 
Type of Sponsor  Other [Medical Technology Company ] 
 
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 Sharmila Pimple  Tata Memorial Hospital  Department of Preventive oncology, 3rd floor, Service block, Tata Memorial Hospital, Dr Ernest Borges road, Parel 400012
Mumbai
MAHARASHTRA 		 9223207939

pimplesa@tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre, Institutional Review Board, Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  screening of women aged 30 to 60 years for cervical cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ARTIFICIAL INTELLIGENCE (AI) FOR VIA IN CERVICAL CANCERSCREENING  The Machine Learning trained & internally validated AI_VIA test software model , that uses Machine Learning computer algorithm techniques using 1,00,000+ images, installed on a platform of a image capture camera device that can analyze digital images of uterine cervix , for more objective interpretation to identify precancerous changes. The Auto-assessment feature of this ML model will classify ecto-cervix into 3 categories which will be color coded and displayed on the screen of tablet as follows: (1) Normal Cervix as Green (2) Abnormal but Benign changes on the cervix as Amber (3) Pre-cancerous & cancerous changes on the cervix as Red Images captured will be interpreted with the help of AI based Machine Learning Model (ML-Model) according to above categories This artificial intelligence (AI) AI_VIA approach, called automated visual evaluation, has the potential to be of particular value in settings with limited access for triage and confirmation of the diagnosis for further treatment. 
Comparator Agent  Colposcopy  Colposcopy will be performed by trained doctors and public health workers. The colposcopist will perform an independent manual assessment aided by a standard colposcope, and the colposcopy impression will be noted as per the SWEDE score standardized criteria.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Sexually active women aged 30–60 years
2. Non Pregnant
3. No history of prior treatment for
cancer of the cervix
4. No history of hysterectomy
5. Healthy enough to undergo pelvic
examination i.e. not seriously ill with
any debilitating condition
 
 
ExclusionCriteria 
Details  1. Women with a known diagnosis of cancer, any other terminal diagnosis
2. Not willing to undergo cervical cancer screening
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will demonstrate the proof-of-principle of an “automated visual evaluation” algorithm applied to archived, digitized cervical images for detection of cervical pre cancer lesions  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of PHW_VIA 2. Assessment of HPV_DNA test
3. Assessment of cervical cytology
4. Colposcopic assessment to detect test positive cases (CIN lesions )
5. Histopathology outcome
 		 1. Immediately after PHW-VIA test 2. Fifteen (15) days after sampling for HPV DNA test 3. Four (4) days after sampling for cervical cytology 4. On same day followed by PHW-VIA test , immediately after colposcopy test 5. Eight to ten ( 8 to 10) days after biopsy 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   23/12/2019 
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   Peer reviewed journals Conference presentations Internal Reports 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In this study, we aim to evaluate the feasibility and clinical performance of  Artificial Intelligence (AI) based visual inspection test (AI_VIA) of a trained Machine Learning Camera model to perform AI based VIA Test with that of the conventional VIA performed by trained Primary Health Care workers (PHW_VIA), and other current evidence based primary screening tests of HPV DNA and conventional cytology.

The study will demonstrate the proof-of-principle of an “automated visual evaluation” algorithm applied to archived, digitized cervical images for detection of cervical pre cancer lesions.

Objective : Comparative evaluation of AI_VIA, HW_VIA, Cervical cytology, and HPV DNA [Hybrid Capture 2 (HC2) test] for detection of cervical intraepithelial neoplasia grades 2 and above (CIN2+).
Study Design: Cross – Sectional Study.
Inclusion criteria: 1. Sexually active women aged 30–60 years 2. Non Pregnant 3. No history of prior treatment for cancer of the cervix 4. No history of hysterectomy 5. Healthy enough to undergo pelvic examination i.e. not seriously ill with any debilitating condition
Exclusion criteria: 1. Women with a known diagnosis of cancer, any other terminal diagnosis 2. Not willing to undergo cervical cancer screening
Sample Size: Sample size for estimating sensitivity and specificity with the 95% confidence level, a total sample size of 600 (which includes 36 subjects with the disease: cervical intraepithelial neoplasia ) to test for non inferiority of the new device using a two-sided binomial test. The prevalence of the disease at 1.6 %
Duration of the study: 12 months

The study participants will be recruited from hospital and community based screening programmes in and around Mumbai India. Trained Medical Social workers will explain the details and the purpose of the study to participants attending the screening clinic. Apparently healthy women in the age group of 30-60 yrs with an intact uterus and no past history of cervical neoplasia will become eligible to participate in the programme. If they are fulfilling the inclusion criteria given above, a written informed consent in the vernacular language (either Hindi or Marathi) will be obtained from the participant and a unique participant identification number will be assigned to the eligible women. They will be enrolled after explaining the study and obtaining written informed consent. All the participants will be interviewed with the help of validated closed ended structured questionnaire will be interviewed to record their basic socio- demographic, personal, medical, reproductive, family planning history. Information will be collected by personal interview and documented as per the details indicated in data collection sheet.

Informed Consenting Process : Medical social worker will explain the study to the eligible participants and invite them to participants in the trial. A written informed consent will be obtained through signature/thumbprint. All the participants who are invited to participate will be given a participant’s information sheet, explaining the study in detail in simple vernacular language. They will be given time to go through it and come back with queries if any. The participants who are willing to participate will then sign the written informed consent form. Left hand thumb impression will be obtained from participants who are not able to sign. Another literate person will be invited to witness the procedure of consent administration and will sign as an impartial witness. The informed consent will clearly describe the purpose, objectives and the process of the study, potential use of the data and how it will be disseminated. Participants will be made aware of their right to refuse to participate. They will be made to understand the confidentiality that will be maintained in the study. Sufficient time will be given to each participant to think upon thereafter. Any doubts that arise out of the information sheet will be completely allayed and no pressure or coercion will be used for their participation.

Post Test Counseling : At the end of all testing procedures post test counseling will be done by the Doctor and Medical Social Worker to explain the significance and the results of the testing procedures performed. The importance of follow up visit to understand the results of screening tests , colposcopy and/ or cervical biopsy will be explained to the women

Treatment: Women with High grade Cervical Intraepithelial Lesion (CIN2) and above lesion will be recommended to seek treatment with cryotherapy or LEEP (Loop Electrosurgical Excision Procedure) or by cold knife conization as per the established protocols for treatment of cervical pre cancers at the Tata Memorial Centre, Mumbai. Women with Invasive Cancers will be referred to further treatment at the Tata Memorial Centre.

Confidentiality and privacy of the participant’s information: The investigators will maintain the confidentiality of the participants in the research project. The names of the study participants will be kept separate from the data / information collected from them by assigning a number to identify research subjects on the questionnaire. The identifying information will be kept in a locked cabinet. The confidentiality and privacy of the participant’s responses would be maintained as per the norms of the Ethics committee. The investigators and personnel involved in the study would be responsible for this. The information collected will not be used by the investigator or other personnel for any purpose other than conducting the study.

BENEFITS:
ï‚·Objective assessment feature will remove the subjectivity of the VIA test reporting performed by primary care workers and also the dependency on trained manpower at primary health centers for performing VIA.
ï‚· Decrease the reliance on repeated training and Quality Control measures required for conventional VIA Training
ï‚· AI_VIA can offer Point of care Triage test in the absence of resources for confirmation of diagnosis such as Colposcopy / Biopsy

Safety and risks to human subjects:  Not Applicable

CONFLICT OF INTEREST:  No conflict of interest in any form




 
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