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Home > "C" Clinical Trials Conditions > Characteristics of Mast Cells in Mastocytosis  Characteristics of Mast Cells in Mastocytosis
Characteristics of Mast Cells in Mastocytosis
For Condition: Mastocytosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will determine what growth factors are involved in promoting and inhibiting mastocytosis-an abnormal increase of mast cells in one or more organ systems. Mast cells release chemicals that can cause itching, blisters, flushing, bone pain, and abdominal pain. Little is known about the disease and there is no cure. Steroids and antihistamines can help reduce some symptoms. Patients from birth to 80 years of age with increased mast cells in at least one organ system may be eligible for this 3-year study. Family members may also be enrolled for genetic testing. Patients will be evaluated yearly at the NIH Clinical Center with the following tests and procedures: - Medical history and physical examination. - Blood samples. - Laboratory blood tests, as medically indicated. - Bone marrow aspiration and biopsy - For the bone marrow aspiration and biopsy, the back hipbone is punctured with a sterile needle. Five milliliters (1 teaspoon) of marrow is withdrawn through a syringe and a 1/2-inch piece of tissue is extracted with a special needle. The blood and bone marrow samples will be used for clinical care and for research to determine if mastocytosis is due to mast cell growth factors or genetic changes. Patients who require further evaluation and tests will have recommendations made to their primary physician. Any patient who requires immediate treatment will be admitted to the hospital. Standard medical treatment may include antihistamines for itching; steroids for severe abdominal symptoms such as cramping, diarrhea, and evidence of increased mast cells determined by an upper GI study; and adrenaline for anaphylactic shock. Patients who do not respond to conventional treatment may be offered participation in an experimental therapy study. Participating family members will have a medical history and a blood sample drawn to look for genetic abnormalities.
Details: This protocol is designed to examine those growth potentiating and inhibiting factors which regulate mast cell number in patients with mastocytosis, and to explore the molecular basis of the disease process in hopes of improving therapy. Patients entered into the study are seen initially and may elect to be reevaluated yearly. The majority of patients to be entered into this protocol are currently followed at NIH on other protocols. Medical workup and treatment are in accordance with standard medical practice. The protocol is for 3 years, to be extended as facilities, faculty, and patients permit.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Subjects include children and adults from birth to 80 years of age. Participants must have histologic evidence of an increased mast cell number in at least one organ system. Must be willing to be seen at the NIH according to protocol guidelines. Routine medical care must be available through their referral physician. Patients with mastocytosis now followed at the NIH on protocol 88-I-0190 will be continued on this study.
Total Enrollment: 300
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 930136; 93-I-0136
Study Start Date: May 14, 1993
Record last reviewed: May 22, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001356
Other Mastocytosis Studies:
1. Characteristics of Mast Cells in Mastocytosis
2. Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec
3. Stem Cell Transplantation to Treat Systemic Mastocytosis
4. Study of Mast Cell Precursors
5. Cytokine Production Patterns in Patients with Systemic Mastocytosis Compared with Atopic Dermatitis and Healthy Individuals
Related Studies:
Other Mastocytosis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Characteristics of Mast Cells in Mastocytosis
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