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临床试验/NCT02254564
NCT02254564已完成不适用

PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei

Seton Healthcare Family5 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
5
主要终点
Identification of DNA sequences within scabies that can be used to identify the parasite through PCR

研究概览

简要总结

The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.

详细描述

The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Male/Female of all ages whose standard clinical treatment produces one or more of the following:
  • Slides from skin scrapings containing scabies mites, eggs, and/or fecal material
  • Slides from skin scrapings of suspected tinea
  • Slides from skin scrapings of demodex mites

排除标准

  • Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.

结局指标

主要结局

Identification of DNA sequences within scabies that can be used to identify the parasite through PCR

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dayna Diven

Physician

Seton Healthcare Family

研究点 (5)

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