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临床试验/NCT03796806
NCT03796806已完成不适用

Methods Validation Assessment for Study of Inflammatory Skin Disease

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
1
试验地点
1
主要终点
Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model

研究概览

简要总结

  1. Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease
  2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.

详细描述

The use of fixed tissue specimens for research studies is attractive, because a large number of relevant specimens can be collected quickly from tissue registry. There is a current lack of knowledge regarding to what extent formalin fixation alters the identification of proteins in the skin with inflammatory dermatoses. This information would be important to assess when determining the limitations (or potentially lack thereof) of using fixed specimens in research.

Collaborators have successfully developed a murine model that can accept human skin xenografts. While those investigators have successfully demonstrated transplantation of healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed human skin using this model, as well as observing the course of this inflammation, are the next steps in advancing this potentially invaluable research modality.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults >18 years with active cutaneous lichen planus with capacity to consent.

排除标准

  • Concurrent skin infection
  • Wound healing disturbances
  • Patients on systemic immunosuppressive medications.
  • Lidocaine allergy
  • Platelets <10,000

结局指标

主要结局

Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model

时间窗: 8 months

Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.

Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.

时间窗: 8 months

Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins.

Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model

时间窗: 8 months

Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia S. Lehman

Professor of Dermatology and Laboratory Medicine and Pathology

Mayo Clinic

研究点 (1)

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