NCT00044122 Study of Factors Regulating Mast Cell Proliferation
| NCT ID | NCT00044122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Mastocytosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2002-09-18 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2002-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will examine growth factors that promote and inhibit mast cell proliferation resulting in mastocytosis, a disease of excessive mast cells in the body. These cells can release chemicals that cause itching, blisters, flushing, bone pain and abdominal pain. Patients up to 80 years of age with mastocytosis may be eligible for this 1-day study. Participants will have one visit at NIH lasting up to 8 hours, during which they will undergo the following tests and procedures: * Medical history and physical examination. * Laboratory studies, if medically indicated. * Blood tests to identify genetic changes important in the growth, development, and functioning of mast cells. * 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 receive an evaluation of their mastocytosis.
Eligibility Criteria
* PATIENT PARTICIPANT INCLUSION CRITERIA: Participants with mastocytosis zero to 80 years of age may participate in telehealth visits, and two to 80 years of age may participate on-site at NIH Clinical Center. Histologic evidence of increased mast cell number by bone marrow and/or skin biopsy or documentation of mastocytosis in the skin supported with a photograph of diagnostic skin lesions Must be under the care of a primary care physician to be enrolled. Ability to provide informed consent. PATIENT PARTICIPANT EXCLUSION CRITERIA: Anemia with hemoglobin less than 8 g/dL, hematocrit less than 24. Any condition that in the opinion of the investigator contraindicates participation in this study. RELATIVE INCLUSION CRITERIA: Two to 80 years of age. A biological relative without the diagnosis of mastocytosis by skin examination or histologic evidence in a skin or bone marrow biopsy Participant has a primary medical care provider outside the NIH Ability to provide informed consent. RELATIVE EXCLUSION CRITERIA: Any condition that in the opinion of the investigator contraindicates participation in this study.
Contact & Investigator
Hirsh D Komarow, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT00044122 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 80 Years, studying Mastocytosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00044122 currently recruiting?
Yes, NCT00044122 is actively recruiting participants. Contact the research team at bolanhy@mail.nih.gov for enrollment information.
Where is the NCT00044122 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00044122 clinical trial?
NCT00044122 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Hirsh D Komarow, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 600 participants.