A Prospective Approach for the Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To use preemptive assessments with sequential chest imaging and BAL measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with HSCT.
研究概览
简要总结
Background:
Stem cell transplants (called hematopoietic stem cell transplantation, or HSCT) are used to treat various diseases. But when the cells for this procedure are donated by someone other than the person who receives the HSCT ( allogeneic HSCT ), the recipient has an increased risk of lung inflammation and scarring. This happens when their immune cells attack healthy lung cells. In this natural history study, researchers will look for the best ways to detect developing lung inflammations earlier after an HSCT.
Objective:
To see if certain tests can detect early signs of lung inflammation in people after HSCT.
Eligibility:
People aged 5 to 70 years who will have HSCT as part of another NIH study.
Design:
Participants will undergo these tests prior to their HSCT. These tests will then be repeated regularly for 2 years:
Ultra-low dose computed tomography (CT) scans. Participants will lie on a table that slides through a machine; the machine uses X-rays to get pictures of the inside of the body. This type of scan uses less radiation than normal CT scans.
Bronchoscopy with lavage: Participants will be sedated. A flexible tube will be inserted through the mouth and into the airways. Salt water will be squirted into the lung, then sucked out to collect cells and fluids from the lung. Another tube with a camera may be inserted into the airways to take pictures.
Blood tests. Blood will be drawn every 2 to 4 weeks.
Pulmonary function tests. Participants will breathe into a machine to test their lung function. They will see how far they can walk in 6 minutes.
详细描述
Study Description:
The primary goal of this proposal is to use preemptive pulmonary imaging, biomarker measurement with surveillance bronchoscopy to improve the early detection of inflammatory injury after allogeneic hematopoietic stem cell transplantation (HSCT). These data may provide early identification of patients at risk for infectious and noninfectious lung diseases and accelerate the development of targeted therapies.
Objectives:
Primary Objective:
To use preemptive assessments with sequential chest imaging and bronchoalveolar lavage (BAL) measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with hematopoietic stem cell transplantation
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
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 5 - 70 years of age
- •Are to be treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorders at the NIH Clinical Center.
- •Ability of subject to understand and the willingness to sign a written informed consent document.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •1. Pregnancy or lactation
- •a. HSCT is not available to pregnant women or lactating women in the intramural program. For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).
研究组 & 干预措施
allogeneic HSCT
Up to 30 men or women, 18 - 70 years of age, who are being treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorder at the NIH Clinical CenterUp to 10 children 5 - 17 years of age who are being treated with allogeneic HSCT for a hematologic malignancies, blood, or immune system disorder at the NIH Clinical CenterNIH Clinical Center
结局指标
主要结局
To use preemptive assessments with sequential chest imaging and BAL measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with HSCT.
时间窗: 30 months
To assess whether surveillance chest tomography and bronchoscopy with lavage detects incipient lung infection and noninfectious lung injury prior to and following HSCT
次要结局
- To use high density proteomic, transcriptomic and metagenomic analysis of specimens from the lung and blood to define mechanisms of altered lung function associated with HSCT.(30 months)