Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005900
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-06-02
Brief Title:
Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
Fairview University Medical Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation HSCT for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications
II Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT
III Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT or at 60 days post-HSCT if there has been no pulmonary complications
II Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT
III Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT or at 60 days post-HSCT if there has been no pulmonary complications
Detailed Description:
PROTOCOL OUTLINE
Patients undergo bronchoscopy with bronchoalveolar lavage BAL prior to allogeneic hematopoietic stem cell transplantation HSCT ELISA assays for cytokines are performed Patients are followed post-HSCT for the development of transplant related pulmonary complications A repeat bronchoscopy with BAL is performed at the time pulmonary complications develop or at day 60 post-HSCT if no complications develop Cytokine assays are repeated
Patients undergo bronchoscopy with bronchoalveolar lavage BAL prior to allogeneic hematopoietic stem cell transplantation HSCT ELISA assays for cytokines are performed Patients are followed post-HSCT for the development of transplant related pulmonary complications A repeat bronchoscopy with BAL is performed at the time pulmonary complications develop or at day 60 post-HSCT if no complications develop Cytokine assays are repeated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-MT-9818 | None | None | None |
| UMN-MT-1999-18 | None | None | None |