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Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells


N/A
N/A
80 Years
Open (Enrolling)
Both
Mastocytosis

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Trial Information

Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells


This protocol is designed to examine those growth potentiating and inhibiting factors which
regulate mast cell number and survival in patients with mastocytosis, and to explore the
molecular basis of the disease process in hopes of improving therapy. Patients will carry
the diagnosis of mastocytosis based on abnormal bone marrow biopsy and aspirate, abnormal
skin biopsy, presence of urticaria pigmentosa, and if available, elevated serum tryptase
level greater than 20 ng/ml and the presence of aberrant mast cell morphology and surface
markers of CD2 and CD25. Medical work-up is in accordance with standard medical practice.
Mastocytosis patients will be children and adults from birth to 80 years of age. The
protocol is designated for up to a 1-year enrollment period; with only a small number of
enrolled patients that will stay on study for more than one visit, based on investigator
assessment of contribution to study objectives. Patients may be asked to re-enter this
protocol at a later time for further research or entry into protocol 98-I-0027. This is not
a therapeutic protocol and does not involve infusion of any manipulated cells, viruses or
DNA constructs into human subjects.

Inclusion Criteria


- INCLUSION CRITERIA:

Birth to 80 years of age.

Histologic evidence of increased mast cell number by bone marrow and/or skin biopsy.

Must be under the care of a primary care physician to be enrolled.

Patients must be able and willing to undergo a bone marrow biopsy. A bone marrow biopsy
will be pre-empted if, during the procedure, the patient experiences significant flushing,
pain, hypotension or tachycardia for any reason, which places the patient at risk. A
patient may decline to have a bone marrow biopsy if the bone marrow sample is only for
research purposes.

Bone marrow biopsy will be performed on children only if medically indicated. Research
samples will be collected at that time only if the procedure does not increase the risks
to the child.

EXCLUSION CRITERIA:

No primary care physician.

Anemia with hemoglobin less than 8 g/dL, hematocrit less than 24.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Dean D Metcalfe, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Allergy and Infectious Diseases (NIAID)

Authority:

United States: Federal Government

Study ID:

020277

NCT ID:

NCT00044122

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Mastocytosis
  • Mastocytosis
  • Urticaria Pigmentosa
  • Classification
  • Tryptase
  • Mutations
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892