跳至主要内容
临床试验/NCT05170425
NCT05170425进行中(未招募)不适用

Observational Registry Study With Sub-analysis (Patients Previously Randomized to LAMBDA 001) to Assess ProsperaTM Performance for Detection of CLAD After Lung Transplant (LAMBDA 002)

Natera, Inc.11 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Natera, Inc.
入组人数
154
试验地点
11
主要终点
Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test

研究概览

简要总结

The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.

详细描述

The LAMBDA 002 registry study is an observational, longitudinal, multicenter study observing patients undergoing lung transplant in one of the following two cohorts:

Cohort 1: Previously enrolled and randomized in LAMBDA 001 (transbronchial biopsy surveillance or Prospera surveillance) and enrolled at least 12 and up to 18 months post-transplant.

Cohort 2: Not previously randomized in LAMBDA 001 (may have been enrolled but randomization did not occur), Prospera testing is part of clinical care and enrolled during less than or equal to 12 months posttransplant.

Primary Objective:

The primary objective of the study is to assess the clinical utility of combining Prospera testing with routine transplant management in detecting acute rejection or infection events in patients receiving Prospera testing as part of their post-transplant clinical care.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percent of donor-derived cell-free DNA (ddcfDNA) measured via the Prospera test

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Natera, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (11)

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