Detecting lung diseases early after stem cell transplants
A Prospective Approach for the Early Detection of Infectious and Noninfectious Lung Diseases Following Allogeneic Hematopoietic Stem Cell Transplantation
This study is testing new ways to spot lung problems early in kids and adults who have had a stem cell transplant to help them get better treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 70 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06093867 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the early detection of lung inflammation and injury in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Researchers will utilize preemptive pulmonary imaging and biomarker measurements through surveillance bronchoscopy to identify early signs of lung issues. Participants aged 5 to 70 will undergo tests before and regularly after their HSCT for two years, including ultra-low dose CT scans and bronchoalveolar lavage. The goal is to enhance the identification of patients at risk for lung diseases and facilitate the development of targeted therapies.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 5 to 70 who are scheduled to receive allogeneic HSCT for hematologic malignancies or immune system disorders.
Not a fit: Patients who are pregnant or lactating will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of lung complications in HSCT patients, potentially improving their outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in early detection of complications post-transplant, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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).
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Anthony F Suffredini, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Gloria Y Pastor, R.N.
- Email: gloria.pastor@nih.gov
- Phone: (301) 402-3484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.