Study of Factors Regulating Mast Cell Proliferation

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00044122
Status
Recruiting

Conditions

  • Bone Marrow
  • Mastocytosis
  • Monoclonal
  • Tryptase

Eligibility Criteria

Sex
ALL
Age
1 Day - 80 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Sep 18, 2002
Status verified
Aug 2025

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Adult Relatives
    Relatives of patient with mastocytosis
  • Arm: Adults with Mastocytosis
    Adults with documented mastocytosis
  • Arm: Pediatric Patients with Mastocytosis
    Pediatric patients with documented mastocytosis
  • Arm: Pediatric Relatives
    Pediatric relatives of patients with mastocytosis

Primary Outcome Measure

To obtain normal and neoplastic human mast cells from the bone marrow and peripheral blood of patients with mastocytosis in order to study the regulation of the proliferation and survival of these cells, and to assess the extent and classificati... [ Time Frame: Patients return to NIH as necessary ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
800-411-1222

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