Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine

NCT ID: NCT02693379

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1041 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-11-30

Brief 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.

Detailed 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.

Conditions

Cervical Precancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

D-VIA

HPV high risk-positive (16, 18, 45, 31, 33, 35, 39, 51, 52, 56, 58, 59, 66, 68) women had a cervical examination using acetic acid (VIA) application and visual inspection.

Group Type: EXPERIMENTAL

D-VIA

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Patrick Petignat

OTHER

Sponsor Role: lead

Responsible Party

Prof. Patrick Petignat

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Petignat, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Saint-Damien Health-Care Centre

Ambanja, Antsiranana, Madagascar

Countries

Madagascar

References

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.

Reference Type: BACKGROUND

PMID: 21351269 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 21822676 (View on PubMed)

Related Links

http://www.worldlifeexpectancy.com/country-health-profile/madagascar

Health Profile Madagascar. World Life Expectancy. Last time accessed: 15.01.2014

http://www.hpvcentre.net/statistics/reports/XWX.pdf

WHO/ICO. Information Centre on HPV and Cervical Cancer (HPV Information Centre) - Human Papillomavirus and Related Cancers in Madagascar. Summary Report 2010. 2010.

Other Identifiers

14-071

Identifier Type: -

Identifier Source: org_study_id