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临床试验/NCT02693379
NCT02693379已完成不适用

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

Prof. Patrick Petignat1 个研究点 分布在 1 个国家目标入组 1,041 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,041
试验地点
1
主要终点
Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • Previous Hysterectomy
  • Conditions that can interfere with visualization of the cervix
  • Pregnancy > 20 weeks
  • Not able to comply with protocol study.

结局指标

主要结局

Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer

时间窗: up to 12 months

Sensitivity and specificity will be calculated using histological results as gold-standard. All lesion Cin2 and worse will be considered as pathological.

次要结局

  • Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA.(up to 12 months)

研究者

发起方
Prof. Patrick Petignat
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Patrick Petignat

Professor

University Hospital, Geneva

研究点 (1)

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