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
|
|
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
|
|
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. |