FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/032299 [Registered on: 25/03/2021] Trial Registered Prospectively
Last Modified On: 24/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   Role of artificial intelligence in detecting cervical cancer 
Scientific Title of Study   Role of visual inspection with acetic acid-artificial intelligence using Easy Cervical Optimiser device in identification of cervical epithelial abnormalities  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayesha Siddiqua 
Designation  Junior Resident(1st year),MS OBG 
Affiliation  Kasturba Medical College, Manipal 
Address  Department Of OBG,Kasturba MEdical College,Manipal

Udupi
KARNATAKA
576104
India 
Phone  8790509701  
Fax    
Email  ayesha.siddiqua@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  DRShyamala G 
Designation  Professor and Head of unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Professsor and head of unit.obg3,Department of OBG,Kasturba medical college ,Manipal

Udupi
KARNATAKA
576104
India 
Phone  8790509701  
Fax    
Email  shyamala.g@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  DRShyamala G 
Designation  Professor and Head of unit 
Affiliation  Kasturba Medical College, Manipal 
Address  Professsor and head of unit.obg3,Department of OBG,Kasturba medical college ,Manipal

Udupi
KARNATAKA
576104
India 
Phone  8790509701  
Fax    
Email  shyamala.g@manipal.edu  
 
Source of Monetary or Material Support  
Applying for PG thesis grant KASTURBA HOSPITAL KASTURBA MEDICAL COLLEGE,MANIPAL 
 
Primary Sponsor  
Name  Ayesha Siddiqua 
Address  Department of OBG,Kasturba medical college,Manipal 
Type of Sponsor  Other [Self] 
 
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 
Ayesha Siddiqua  Kasturba Hospital,Department of OBG,KMC Manipal  Department of OBG,Kasturba Medical College,Manipal
Udupi
KARNATAKA 
8790509701

ayesha.siddiqua@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,KMC MANIPAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.Women between 30- 65 years who are
Subjected to routine cervical screening
2.Includes those scheduled for colposcopic evaluation for indications-
-Positive Pap test (ASCUS/ASC-H/LSIL/HSIL/Invasive -carcinoma (Bethesda classification)
-HR-HPV positive
-Clinically suspicious cervix
 
 
ExclusionCriteria 
Details  1.Obvious growth on cervix (Ca cervix)
2.Unmarried woman
3.Pregnant/ postpartum
4.Menstruating on the day of the visit
5.Genital prolapse grade 2 and beyond
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Comparison of VIA –AI using ECO device with colposcopy diagnosis in identification of cervical epithelial abnormalities for screen positive women
2.Comparison of VIA –AI using ECO device with histopathology reports
3.Comparison of VIA –AI using ECO device with screen test (Pap smear/ HPV) results
 
4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
1.Analysis of sensitivity,specifivity of VIA-AI using ECO device with standard screening procedures of carcinoma cervix  1 YEAR 
 
Target Sample Size   Total Sample Size="326"
Sample Size from India="326" 
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)   31/03/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cancer of the uterine cervix is the second most common cancer among Indian women, and accounts for 25% of global mortality due to cervical cancer. This is due to higher incidence, and late diagnosis of cervical cancer. Some of the commonly used screening tests for early detection of cervical cancer are Pap smear, HPV-DNA and visual inspection with acetic acid (VIA). Pap smear is the most commonly used method for cervical cancer screening. It depends on availability of laboratory facility and medical experts for smear preparation and analysis, which is lacking in developing countries. VIA evaluates the cervix for acetowhite (AW) regions which are formed when precancerous lesions combine with acetic acid. It does not depend on well-established laboratory facility and hence is a cost-effective test. It is a simple test as it is based on visual examination of the cervix after the application of acetic acid. Thus, it is well suited for screening in developing countries.VIA is a suitable test for low-resource settings as far as the simplicity of the test is considered, it requires skilled personnel for the evaluation of the acetowhite regions. Depending on the skills of the ones who perform the test, accuracy of VIA varies widely, with significantly higher sensitivity and specificity when observed by physicians than by nurses . An automated system for cervix image analysis might be able to overcome this problem, providing objective and repeatable evaluations. Advances in digital imaging and image processing have facilitated the acquisition of good-quality cervix images during the VIA procedure. At present, digital images of the cervix are acquired using a digital camera or a digital colposcope. Acquisition of cervix images using the digital camera and subsequent analysis of the images by skilled personnel is called cervicography. Since images acquired can be stored and sent over the Internet, it enables remote diagnosis. Digital colposcopy facilitates the acquisition of high-magnification cervix images. However, it is expensive and hence is not feasible for screening in resource-poor settings. An android device with an inbuilt app to acquire images and provide instant results would be an obvious choice in resource-poor settings. Our overall goal is to analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy and ROC  of Easy Cervical Optimiser(EC0) device which facilitates acquisition and processing of images with an inbuilt image processing algorithm. Such a system would be useful to augment the capability of a lay health worker performing the VIA examination to offer instant decision whether the individual requires further evaluation or not. 

 
Close