Study of Factors Regulating Mast Cell Proliferation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-80
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

PATIENT PARTICIPANT

Disqualifiers

None

Trial population

primary clinical

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

700 Participants
are grouped into 4 trial groups
Group A: Adult Relatives
Group B: Adults with Mastocytosis
Group C: Pediatric Patients with Mastocytosis
Group D: Pediatric Relatives

Trial outcomes

Primary outcomes

1

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...

continuing collection of cells from subjects with mastocytosis for ongoing experimentation in laboratory

Time frame
Patients return to NIH as necessary

Secondary outcomes

Other outcomes

Sponsors and contacts

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