Lung Allograft Rejection Gene Expression Observational (LARGO) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- XDx
- 入组人数
- 2,044
- 试验地点
- 20
- 主要终点
- The absence of histologic rejection and normal or unchanged allograft function.
研究概览
简要总结
The objective of the LARGO Study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with the study endpoints. The primary objective is to use gene expression profiling of peripheral blood mononuclear cells to differentiate between the absence and presence of acute cellular rejection. The secondary objectives are to use other genomic and proteomic technologies to analyze RNA and protein in blood samples in relation to related clinical conditions. The overall goal is to apply novel molecular insights in the development of non-invasive molecular diagnostic tests for lung transplantation.
详细描述
LARGO is a prospective, multi-center, international observational study with participating centers in the United States, Canada and Europe. The target enrollment for study completion is 2,100 subjects.
At each study visit, blood specimens are collected from subjects, processed and stored in the sample archive, with corresponding patient information entered into the clinical database. The analysis plan for each study objective includes a defined sample selection protocol that stipulates the inclusion and exclusion criteria for both patients and samples, and also the required number of blood specimens for the molecular analyses to achieve statistical significance.
The diagnosis and treatment of acute cellular rejection remains a clinical management priority that is currently based on transbronchial biopsy. Gene expression profiling is a technology based on molecular biology that measures changes in the RNA levels of different genes expressed by circulating mononuclear cells in the peripheral blood. A key goal of the project is to use gene expression profiling to differentiate between the absence and presence of lung allograft acute cellular rejection, with the aim of using this novel information to develop a non-invasive diagnostic testing alternative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lung and heart-lung transplant recipients who consent to participate and have transbronchial biopsy at the enrolling center during the study period
排除标准
- 未提供
结局指标
主要结局
The absence of histologic rejection and normal or unchanged allograft function.
时间窗: Scheduled clinic visit
Allograft function as determined via pulmonary function tests.
时间窗: Scheduled clinic visit
Rejection episodes of at least moderate histologic grade which resulted in treatment of the patient with additional corticosteroids, anti-T cell antibodies, or total lymphoid irradiation.
时间窗: Scheduled clinic visit
Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.
时间窗: Scheduled clinic visit
Obliterative Bronchiolitis diagnosed pathologically by biopsy or by a progressive decline in pulmonary function tests consistent with a diagnosis of Bronchiolitis Obliterans Syndrome (BOS).
时间窗: Scheduled clinic visit
Infections other than CMV, e.g. bacterial, other viral, and fungal infections.
时间窗: Scheduled clinic visit
次要结局
- All cause mortality.(Scheduled clinic visit)
- Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.(Scheduled clinic visit)
- Graft Failure or Retransplantation.(Scheduled clinic visit)
- Lymphoproliferative disorder (aka post-transplant lymphoma).(Scheduled clinic visit)
- Allograft dysfunction during the study period.(Scheduled clinic visit)
- Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.(Scheduled clinic visit)