Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047918
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-10-22
Brief Title:
Blood Factors in Mastocytosis and Unexplained Anaphylaxis and Flushing
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigation of Hematologic Parameters in Mastocytosis and Idiopathic Anaphylaxis
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
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:
This study will 1 identify characteristics of bone marrow mast cells in patients with unexplained anaphylaxis and flushing or with mastocytosis and 2 determine whether mastocytosis might be the underlying cause of unexplained anaphylaxis in some patients with this condition Anaphylaxis is a hypersensitivity reaction in which patients may have flushing hives stuffy nose red itchy eyes difficulty breathing swelling of the tongue throat palms and soles abdominal cramping lightheadedness decreased blood pressure and loss of consciousness Although allergens are a common cause of anaphylactic episodes no cause can be identified in up to 50 percent of patients who have recurrent events Mastocytosis is a disease of excessive mast cells in tissues such as skin and bone marrow These cells can release chemicals that result in itching blisters flushing bone pain and abdominal pain
Patients 18 years of age and older who have episodes of anaphylaxis or flushing with no apparent cause or who have mastocytosis may be eligible for this study Participants will have a medical history and physical examination blood tests to identify genetic changes that are important in the growth development and functioning of human mast cells and bone marrow aspiration and biopsy For the bone marrow procedure the skin over the hipbone and the outer surface of the bone itself are numbed with local anesthesia Then a special needle is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe Another needle is inserted into the same area to collect a small piece of the bone marrow Additional procedures may include allergen testing urinalysis and 24-hour urine collection
Participants will return to NIH for reassessment of disease status in 12 to 18 months The follow-up evaluation will include a history and physical examination blood tests possible repeat bone marrow and aspiration in patients whose clinical signs or symptoms change significantly and other tests as clinically indicated
First-degree relatives parents children siblings may be enrolled in limited instances to provide a blood sample for genetic analysis related to mast cell development and function for comparison with that of patients when they have similar symptoms
Patients 18 years of age and older who have episodes of anaphylaxis or flushing with no apparent cause or who have mastocytosis may be eligible for this study Participants will have a medical history and physical examination blood tests to identify genetic changes that are important in the growth development and functioning of human mast cells and bone marrow aspiration and biopsy For the bone marrow procedure the skin over the hipbone and the outer surface of the bone itself are numbed with local anesthesia Then a special needle is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe Another needle is inserted into the same area to collect a small piece of the bone marrow Additional procedures may include allergen testing urinalysis and 24-hour urine collection
Participants will return to NIH for reassessment of disease status in 12 to 18 months The follow-up evaluation will include a history and physical examination blood tests possible repeat bone marrow and aspiration in patients whose clinical signs or symptoms change significantly and other tests as clinically indicated
First-degree relatives parents children siblings may be enrolled in limited instances to provide a blood sample for genetic analysis related to mast cell development and function for comparison with that of patients when they have similar symptoms
Detailed Description:
Anaphylaxis is a severe systemic hypersensitivity reaction caused by release of mediators from mast cells and basophils Signs and symptoms of anaphylaxis may include generalized flushing hives stuffy nose red and itchy eyes difficulty in breathing swelling of the tongue throat palms and soles gastrointestinal cramping lightheadedness and loss of consciousness Although most common causes of anaphylaxis include foods drugs and stinging insects a causative factor is not identified in up to 50 of the patients with recurrent anaphylactic episodes Mast cells are important mediators of anaphylaxis This study will examine the hypothesis that some patients with unexplained anaphylaxis may have systemic mastocytosis a disorder of pathologic mast cell proliferation as an underlying cause In addition it will investigate hematopoietic cells which result in their tissue mast cells being more susceptible to degranulation The study will enroll patients with mastocytosis with or without flushing or anaphylaxis and patients with unexplained flushing or anaphylaxis Patients will receive a clinical evaluation blood tests and a bone marrow biopsy and aspirate Research studies planned include flow cytometric analysis of blood and bone marrow cells investigation of mutations or polymorphisms in genes involved in mast cell growth and differentiation determination of surrogate disease markers and examination of mast cell growth and function The study will improve the understanding of the mechanisms involved in anaphylactic reactions which could in turn lead to development of strategies to better prevent or treat the episodes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0010 | None | None | None |