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CTRI Number  CTRI/2022/10/046770 [Registered on: 25/10/2022] Trial Registered Prospectively
Last Modified On: 23/10/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Smartphone based application for screening of cervical cancer 
Scientific Title of Study   Assessment of feasibility and efficacy of a smart phone image-based application (Gyneye) as a screening tool and background knowledge, attitude and practices on cervical cancer screening among health care workers at a tertiary cancer center: A pilot study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarita Kumari 
Designation  Assistant Professor of Gynaecologic Oncology 
Affiliation  National Cancer Institute, Jhajjar, AIIMS, New Delhi 
Address  Academic block, Third floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  01126593221  
Fax    
Email  sarita2325@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sarita Kumari 
Designation  Assistant Professor of Gynaecologic Oncology 
Affiliation  National Cancer Institute, Jhajjar, AIIMS, New Delhi 
Address  Academic Block, Third Floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences,New Delhi

South
DELHI
110029
India 
Phone  0112659321  
Fax    
Email  sarita2325@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sarita Kumari 
Designation  Assistant Professor of Gynaecologic Oncology 
Affiliation  National Cancer Institute, Jhajjar, AIIMS, New Delhi 
Address  Academic block, Third floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  01126593221  
Fax    
Email  sarita2325@gmail.com  
 
Source of Monetary or Material Support  
National Cancer Institute, Jhajjar, AIIMS, New Delhi 
 
Primary Sponsor  
Name  Sarita Kumari 
Address  Academic block, Third floor, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, 110029 
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 
Sarita Kumari  National Cancer Institute, Jhajjar, AIIMS, New Delhi  Out patient Department, Department of Gynaecologic Oncology
Jhajjar
HARYANA 
9717828537

sarita2325@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening for cervical cancer 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil   nil  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1) Women > 30 years of age
2) No cervical screening in the last 5 years
3) Willing to participate in the study and sign an informed consent
 
 
ExclusionCriteria 
Details  1) Pregnant or delivered < 3 months ago
2) Currently menstruating
3) Previous history of CIN or cervical cancer
4) Previous history of cervical procedures/hysterectomy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the performance of a smartphone image-based application (Gyneye) for cervical cancer screening.
2. To compare the diagnostic accuracy of Gyneye with HPV DNA testing.

 
2 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the knowledge, attitude and practices on cervical cancer screening among health care workers using a self-administered structured questionnaire.  Baseline

 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   31/10/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cervical cancer (CC) continues to be an important public health problem in India, being the second most common cancer among women and bearing nearly one-fifth of the global burden.1 The national programme for screening of common cancers, which has been rolled out as part of NPCDCS, has included screening for cervical cancer by visual inspection with acetic acid (VIA). Although this has been initiated in nearly 200 districts, the details of implementation, training, quality assurance, and linkages for referral are still being developed and the diagnosis made with this method is subjective and has a limited quality control.2,3   The latest World Health Organization (WHO) guidelines for screening of cervical cancer recommends human papilloma virus deoxy-ribonucleic acid (HPV DNA) testing as the primary screening tool among general population of women.4 This is based on the superior performance of the HPV DNA test in terms of sensitivity and specificity, greater reproducibility and objectivity, and much lower incidence of subsequent cancer in women who test negative for HPV DNA.5,6 This makes one or two rounds of HPV testing a more suitable method for low resource settings but its widespread availability and cost is still a major hurdle.

To assist in easier recognition of cervical intraepithelial neoplasia (CIN), digital pictures taken during VIA with a camera is being adopted by many with encouraging results.7,8 A smartphone device can easily provide the light and magnification needed to effectively evaluate the cervix. Furthermore, the increasing prevalence of smartphone-use in low-resource settings makes it an ideal low-cost device. Use of smartphones and apps in public health is almost universal, however studies evaluating the usefulness of smartphones in the detection of CC are still limited. Research teams have developed programs to increase accuracy of diagnosis from smartphone pictures. Recently, several studies revealed that digital images taken with a smartphone after VIA may be useful for detecting CIN2.9,10 Another study found a correlation between smartphone-based histological diagnoses and colposcopic findings in women with abnormal cervical cytology.11 Gallay et al. evaluated the quality of smartphone images to assess feasibility and usability of a mobile application in low-resource settings. Pictures were taken using a Samsung Galaxy S5 and a phone application called “Exam” was used to classify images. A total of 208 consecutive pictures were assessed by observers and quality was judged as adequate for diagnoses in 93.3% of cases.12 Tran et al. reported a sensitivity of 71.3% (95% CI 67–75.7) and a specificity of 62.4% (95% CI 57.5–67.4) for CIN2+ detection from images taken by smartphones.13 However, current evidence regarding the use and benefits for implementation is still weak, as there are no randomized controlled trials (HPV versus digital images) or large prospective studies. Another advantage of smartphones is that the digital images can be sent to an expert colposcopist for review compared with conventional colposcopy, which is expensive and not always available at all levels of care.

At National Cancer Institute, Jhajjar conventional colposcope is not available yet and is currently under the purchasing process. Hence we aim to use Gyneye as a screening and diagnostic tool and assess its diagnostic accuracy as compared to HPV DNA testing to detect CIN2+. In future, it might be possible to use it for community screening and treatment with better accuracy (less false positives) than HPV DNA testing.

There has been considerable progress in both understanding and availability of tools for CC prevention, yet there is little awareness or access among the target population. Understanding the factors associated with the underutilization of screening is important in order to increase overall CC screening rates and eventually reduce cancer related morbidity and mortality. Health care workers at a tertiary care cancer center constitute a knowledgeable class and is expected to have satisfactory screening rates. However there are no prior published studies and we aim to assess the knowledge, attitude and practices on CC screening among this population.

 

Aim: To assess the feasibility and performance of a smart phone image-based application (Gyneye) as a screening tool and background knowledge, attitude and practices on cervical cancer screening among health care workers at a tertiary cancer center.

 
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