Clinical trial NCT02693379: Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine
Official title: Cervical Cancer Screening in Madagascar: Usability of Mobile Telemedicine for Detection of Precancerous Lesions From Smartphone Photos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Precancer
Keywords: cervical cancer
HPV
VIA
screening
smartphone
telemedicine
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 1041
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer
timeFrame: up to 12 months
Secondary outcomes:
measure: Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA.
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Ambanja
country: Madagascar
facility: Saint-Damien Health-Care Centre
state: Antsiranana
Study officials:
affiliation: University Hospital, Geneva
name: Patrick Petignat, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Marquardt K. [Correlation of cervical cytology and histology]. Pathologe. 2011 Nov;32(6):491-6. doi: 10.1007/s00292-011-1479-2. German.