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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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12 December 2020 |
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Main ID: |
NCT03050788 |
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Date of registration:
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09/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
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Scientific title:
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Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma |
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Date of first enrolment:
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March 10, 2017 |
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Target sample size:
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363 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03050788 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Dongkyun Kang, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
i. = 18 years old ii. Clinically suspected KS iii. Presence of suspected KS lesions in
areas which are considered safe to biopsy by the Ugandan providers, which means all areas
of the skin except for the mouth and eye.
Exclusion Criteria:
i. Presence of suspected KS lesions exclusively on the mouth or eye unless clinical
specialists trained in biopsy of the mouth or eye are available locally to biopsy the mouth
or eye. Oral and eye sites would typically only be biopsied when clinical diagnosis has
proved to be problematic and definitive diagnosis is needed to inform a treatment plan.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Kaposi Sarcoma
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Intervention(s)
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Device: Smartphone confocal microscopy
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Primary Outcome(s)
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Feasibility of diagnosing Kaposi sarcoma using the smartphone confocal microscopy
[Time Frame: Approximately 20 minutes (10 minutes for in vivo imaging)]
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Secondary ID(s)
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2016P002672
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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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