Clinical trial · Interventional
Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine
Cervical Cancer Screening in Madagascar: Usability of Mobile Telemedicine for Detection of Precancerous Lesions From Smartphone Photos
NCT02693379CI-TRIAL-00021156completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Precancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D-VIA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- D-VIA
- description
- 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.
- interventionNames
- Device: D-VIA
Primary outcomes (1)
- 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
- description
- Sensitivity and specificity will be calculated using histological results as gold-standard. All lesion Cin2 and worse will be considered as pathological.
Secondary outcomes (1)
- measure
- Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDFerlay 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. PMID 21351269
- BACKGROUNDMarquardt K. [Correlation of cervical cytology and histology]. Pathologe. 2011 Nov;32(6):491-6. doi: 10.1007/s00292-011-1479-2. German. PMID 21822676