This study is currently recruiting participants.
Number
001742-H
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 5 Years Max Age: 70 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women
Keywords
allogeneic hematopoietic stem cell transplantation (HSCT); early detection of inflammatory injury
Recruitment Keyword(s)
None
Condition(s)
allogeneic hematopoietic stem cell transplantation (HSCT)
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
NIH Clinical CenterNational Heart, Lung, and Blood Institute
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.
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INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Male or female, aged 5 - 70 years of age 3. Are to be treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorders at the NIH Clinical Center. 4. Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: 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).
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Stated willingness to comply with all study procedures and availability for the duration of the study.
2. Male or female, aged 5 - 70 years of age
3. Are to be treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorders at the NIH Clinical Center.
4. Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
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).
Principal Investigator
Referral Contact
For more information: