Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pivotal Trials: Evaluation of a Rapid Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in the United States|
- Specificity [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Specificity will be presented for the CL Detect™ Rapid Test device against the reference method (microscopy). Specificity will be calculated as the number of true negatives divided by the sum of the number of true negatives plus the number of false positives times 100%.
- False positive rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]α, type 1 error, calculated as 1-specificity times 100%
- False negative rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]β, type 2 error, calculated as 1-sensitivity times 100%
Biospecimen Retention: Samples With DNA
dental broach samples in lysis buffer
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||April 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Skin ulcers. No intervention. Subjects will be followed up by their respective primary providers.
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Mark Lebwohl, MD||Mount Sinai School of Medicine|