Liquid Biopsies for Lung Allograft Damage Classification
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Damage distinction
研究概览
简要总结
LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this.
The current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. The specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after LTx. An in-house-developed PCR-based cell-free-DNA methodology (cf-DNA) will be used for allograft damage and combined with specific other biomarkers to identify damage type. The current clinical golden standard for damage identification will be performed at every sampling instance.
The research will be a single-centre prospective observational cohort study. The control samples at all time points will consist of the samples without allograft damage. Blood will be drawn at fixed time points and clinical events. All analyses will be performed at a separate lab, blinded to the patient's status.
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研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Luing Transplanted and followed up within the reach of the study paricipating centres.
- •A good understanding to read and write within the languages in which the consent is provided.
排除标准
- •Not Lung Transplanted or not followed up within the reach of the study paricipating centres.
- •No good understanding to read and write within the languages in which the consent is provided.
结局指标
主要结局
Damage distinction
时间窗: One month, three months, one year, three years, five years
Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.
次要结局
- Damage detection Limit(One month, three months, one year, three years, five years)
研究者
Jesper Magnusson
MD, PhD, Associate professor
Vastra Gotaland Region
