跳至主要内容
临床试验/NCT00816257
NCT00816257已完成不适用

Lung Transplant Specimen Repository and Data Registry Protocol

Karen Wood1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
data registry and lung tissue repository

研究概览

简要总结

All patients enrolled in the registry will be recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts). During the routine management of lung recipients frequent surveillance of the lung allograft is necessary. This routinely involves: measurement of pulmonary functions, chest radiography, collection of peripheral blood to assess other organ function and monitor therapeutic drug levels, and bronchoscopic evaluation allowing for collection of lung lavage fluid and lung tissue biopsy. This surveillance normally follows a set schedule during the first one to two years following the transplant procedure. Surveillance is routinely performed at weeks 2, 8, 12, 24, 36, and 52 during the first year following the transplant procedure. Additional surveillance may be performed at any time when clinically indicated for the optimal management of the recipient. Information and specimens collected from each of these encounters will be entered in the data registry and specimen repository.

详细描述

The collection of disposable lung allograft (transplant tissue samples), blood samples and information from medical records for storage, future analysis and research. Stored samples will be available to other researchers who have obtained separate review and approval from an ethics committee called an Institutional Review Board.

Immediately prior to the transplant surgery, the surgeon or pulmonologist will routinely examine the lungs via bronchoscopy during which subjects will be medicated for pain.

The samples that are obtained during this and post-surgery (clinically scheduled) bronchoscopies, including bronchial lavage, are either sent to pathology or are discarded if they do not qualify to go to pathology. For this research, the researchers are asking that the samples that do not qualify for pathology be placed into the repository instead of being thrown away.

研究设计

研究类型
Observational
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

  • recipients of single and double lung transplantation (bilateral sequential, heart-lung, or living related donor grafts).

排除标准

  • 未提供

结局指标

主要结局

data registry and lung tissue repository

时间窗: ongoing

次要结局

未报告次要终点

研究者

发起方
Karen Wood
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karen Wood

Karen Wood M.D.

Ohio State University

研究点 (1)

Loading locations...

相似试验