Anaphylaxis Clinical Trial
Official title:
Investigation of Hematologic Parameters in Mastocytosis and Idiopathic Anaphylaxis
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.
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. ;
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