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NCT02470273 · ClinicalTrials.gov registry record
Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
A clinical trial, sponsored by Rockefeller University.
- Completed
- Registry status
- 143
- Enrollment target
NCT02470273 is a clinical trial that has completed, run by Rockefeller University. The registered enrollment target is 143 participants.
The verdict
NCT02470273 has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- 143 participants
- Enrollment target
Study Summary
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2015-08-01 |
| Est. Completion | 2021-05-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02470273
The ClinicalTrials.gov registry entry for NCT02470273 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02470273 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02470273 about?
NCT02470273 is a clinical study titled "Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)". The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three exter...
What is the current status of trial NCT02470273?
This trial is currently completed. The enrollment target is 143 participants. The study started on 2015-08-01. Estimated completion is 2021-05-11.
Who is sponsoring clinical trial NCT02470273?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
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