Study of Factors Regulating Mast Cell Proliferation

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

1 days - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

700 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• 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 \< 8 g/dL, hematocrit \< 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.

Study population

primary clinical

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study start

Sep 18, 2002 Actual

Primary completion

Not reported

Study completion

Not reported

First posted

Aug 19, 2002 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts