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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 March 2016 |
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Main ID: |
NCT02693379 |
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Date of registration:
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08/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine
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Scientific title:
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Cervical Cancer Screening in Madagascar: Usability of Mobile Telemedicine for Detection of Precancerous Lesions From Smartphone Photos |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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1041 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02693379 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Madagascar
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Contacts
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Name:
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Patrick Petignat, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpitaux Universitaires de Genève |
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Key inclusion & exclusion criteria
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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.
Age minimum:
30 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical Precancer
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Intervention(s)
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Device: D-VIA
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Primary Outcome(s)
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Differences in sensitivity and specificity of VIA examination (control) and digital VIA to detect cervical cancer and pre-cancer
[Time Frame: up to 12 months]
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Secondary Outcome(s)
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Overall agreement between diagnoses based on VIA examination (control) and diagnoses for the same patient based on digital VIA.
[Time Frame: up to 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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