Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine

Cervical Precancer Clinical Trial

Official title:

Cervical Cancer Screening in Madagascar: Usability of Mobile Telemedicine for Detection of Precancerous Lesions From Smartphone Photos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693379
• Other study ID #: 14-071
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: February 22, 2016
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether smartphone photos may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with conventional VIA, for human papillomavirus (HPV) positive women.

Description:

Background: Cervical cancer is the leading cause of cancer death in females in Madagascar. In this country, a large-scale screening of precancerous lesions with cytology is hardly possible, because of the lack of specialists and infrastructures. Visual inspection of the cervix with application of 5% acetic acid (VIA) is an inexpensive alternative but very subjective since it depends on the examiner's experience. Mobile telemedicine is a very promising tool in order to assist non-expert health-care workers in rural area for cervical cancer screening.

Objective: To assess if Smartphone may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA) compared with conventional VIA, for women testing positive for human papillomavirus (HPV).

Material and method: On-site health care workers will be trained in VIA. Prescreened HPV-positive women will be referred to VIA evaluation, during which digital images with a smartphone (D-VIA) will be taken for later evaluation by a VIA specialist in Geneva linked by telemedicine. Women with positive VIA results will be treated with cold coagulation if eligible. Histological results will be considered as gold standard. The results will be analyzed with Cohen's kappa coefficient, Mcnemar's test and Bonferroni's adjustment for multiple comparisons to assess the performance of D-VIA.

Expected results: Based on the results of this project, the investigators will develop an educational training and quality assurance program for health providers for VIA and so contribute to a scaling-up of cervical cancer control. An appropriate triage by VIA will reduce not only an excessive referral rate but also an excessive treatment delay, giving the possibility of a "screen (HPV), see (VIA/D-VIA), and treat" program in a single or two visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1041
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

Inclusion Criteria:

• 30-49 years

• HPV-positive

• Attending the cervical cancer screening program conducted by the Saint-Damien Health-Care Centre

• Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

Exclusion Criteria:

• Previous Hysterectomy

• Conditions that can interfere with visualization of the cervix

• Pregnancy > 20 weeks

• Not able to comply with protocol study.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Precancer
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Device:
• D-VIA
D-VIA images were captured during the cervical examination with a smartphone. Biopsies and cytological samples were taken on all patients and analyzed for gold standard results. Images were shown to off site experts. D-VIA and VIA diagnoses were then compared. Women who were diagnosed on-site as pathological underwent appropriate treatment at the same consultation. Women who were diagnosed as pathological later by histopathological analyses were asked to return to the clinic for treatment.

Locations

Country	Name	City	State
Madagascar	Saint-Damien Health-Care Centre	Ambanja	Antsiranana

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Patrick Petignat

Country where clinical trial is conducted

Madagascar, 

References & Publications (2)

Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. — View Citation

Marquardt K. [Correlation of cervical cytology and histology]. Pathologe. 2011 Nov;32(6):491-6. doi: 10.1007/s00292-011-1479-2. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer	Sensitivity and specificity will be calculated using histological results as gold-standard. All lesion Cin2 and worse will be considered as pathological.	up to 12 months	No
Secondary	Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA.		up to 12 months	No

External Links

•   Health Profile Madagascar. World Life Expectancy. Last time accessed: 15.01.2014
•   WHO/ICO. Information Centre on HPV and Cervical Cancer (HPV Information Centre) - Human Papillomavirus and Related Cancers in Madagascar. Summary Report 2010. 2010.