Study of Factors Regulating Mast Cell Proliferation

  • STATUS
    Recruiting
  • participants needed
    550
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 12 March 2021

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.

Description

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 > 20 ng/ml and the presence of aberrant mast cell morphology and surface markers of CD2 and CD25. Mastocytosis patients will include children and adults from two years to 80 years of age. Unaffected relatives (age 2 to 80 years) may also be enrolled. 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. Participants will undergo standard physical exam, medical history review, and blood collection for clinical and research laboratory evaluations. We will collect clinical data and biological specimens for research evaluation from individuals undergoing clinically indicated diagnostic procedures. Some patients may participate in research evaluations including buccal swab collection, dietary intake assessment, stool collection, exercise challenge, microbiome studies, and activity tracking. These studies are optional. Patients may be asked to re-enter this protocol at a later time for further follow-up.

Details
Condition Bone Marrow, Dermatosis, TRYPTASE, Urticaria Pigmentosa, Mastocytosis, Congenital Skin Diseases, Skin Conditions, Monoclonal, bone marrow procedure
Clinical Study IdentifierNCT00044122
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on12 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 2 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Bone Marrow or Monoclonal or Mastocytosis or Skin Conditions or Dermatosis or Congenital Skin Diseases or Urticaria Pigmentosa or TRYPTASE?
Do you have any of these conditions: Dermatosis or Bone Marrow or Monoclonal or bone marrow procedure or Congenital Skin Diseases or Skin Conditions or TRYPTASE or Urticaria Pigmentosa or...?
Do you have any of these conditions: Congenital Skin Diseases or Skin Conditions or Dermatosis or Mastocytosis or bone marrow procedure or Monoclonal or Bone Marrow or TRYPTASE or Urticar...?
Do you have any of these conditions: bone marrow procedure or Skin Conditions or Mastocytosis or TRYPTASE or Urticaria Pigmentosa or Bone Marrow or Dermatosis or Congenital Skin Diseases ...?
Do you have any of these conditions: Urticaria Pigmentosa or Congenital Skin Diseases or Bone Marrow or bone marrow procedure or Mastocytosis or TRYPTASE or Skin Conditions or Dermatosis ...?
Do you have any of these conditions: Congenital Skin Diseases or Monoclonal or Dermatosis or TRYPTASE or Mastocytosis or bone marrow procedure or Bone Marrow or Urticaria Pigmentosa or Sk...?
Do you have any of these conditions: Dermatosis or Urticaria Pigmentosa or Congenital Skin Diseases or bone marrow procedure or Mastocytosis or Monoclonal or Skin Conditions or Bone Marro...?
Do you have any of these conditions: bone marrow procedure or Monoclonal or Congenital Skin Diseases or Mastocytosis or Dermatosis or Skin Conditions or Urticaria Pigmentosa or Bone Marro...?
Do you have any of these conditions: Congenital Skin Diseases or TRYPTASE or bone marrow procedure or Mastocytosis or Bone Marrow or Urticaria Pigmentosa or Dermatosis or Skin Conditions ...?
Do you have any of these conditions: Monoclonal or Bone Marrow or TRYPTASE or Dermatosis or Mastocytosis or Skin Conditions or Congenital Skin Diseases or Urticaria Pigmentosa or bone mar...?
Do you have any of these conditions: Congenital Skin Diseases or Dermatosis or Mastocytosis or TRYPTASE or Bone Marrow or Skin Conditions or Monoclonal or Urticaria Pigmentosa or bone mar...?
Do you have any of these conditions: Monoclonal or Urticaria Pigmentosa or Congenital Skin Diseases or Dermatosis or Mastocytosis or bone marrow procedure or TRYPTASE or Skin Conditions o...?
Do you have any of these conditions: Monoclonal or Congenital Skin Diseases or Skin Conditions or bone marrow procedure or Urticaria Pigmentosa or Bone Marrow or TRYPTASE or Dermatosis or...?
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
Subject has a primary medical care provider outside the NIH
Ability to provide informed consent

Exclusion Criteria

Any condition that in the opinion of the investigator contraindicates
participation in this study
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