Smartphone based application for screening of cervical cancer
- Conditions
- Screening for cervical cancer
- Registration Number
- CTRI/2022/10/046770
- Lead Sponsor
- Sarita Kumari
- 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.2,3The 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 200
- 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.
- Pregnant or delivered < 3 months ago 2) Currently menstruating 3) Previous history of CIN or cervical cancer 4) Previous history of cervical procedures/hysterectomy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate the performance of a smartphone image-based application (Gyneye) for cervical cancer screening. 2 weeks 2.To compare the diagnostic accuracy of Gyneye with HPV DNA testing. 2 weeks
- Secondary Outcome Measures
Name Time Method 1.To assess the knowledge, attitude and practices on cervical cancer screening among health care workers using a self-administered structured questionnaire. Baseline
Trial Locations
- Locations (1)
National Cancer Institute, Jhajjar, AIIMS, New Delhi
🇮🇳Jhajjar, HARYANA, India
National Cancer Institute, Jhajjar, AIIMS, New Delhi🇮🇳Jhajjar, HARYANA, IndiaSarita KumariPrincipal investigator9717828537sarita2325@gmail.com