Clinical trial Recruiting at 1 site Observational Ages 1 Day to 80

Examining factors that affect mast cell growth in mastocytosis

Official title: Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells

Run by National Institutes of Health Clinical Center (CC) · NCT00044122 · Data updated 2026-11-12

This study is trying to understand what causes mast cells to grow too much in people with mastocytosis, so we can find better treatments for them.

Quick facts

Study typeObservational
Ages1 Day to 80 Years
SexAll
Enrollment700 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedSeptember 18, 2002
Registry record updatedNovember 10, 2026
Trial IDNCT00044122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 0 to 80 with a confirmed diagnosis of mastocytosis.

Probably not a fit

Patients with severe anemia or other conditions that contraindicate participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the growth factors that influence mast cell proliferation in patients with mastocytosis, a condition characterized by an excess of mast cells. Participants, aged 0 to 80, will undergo a comprehensive evaluation at the NIH Clinical Center, including medical history, physical exams, blood tests, and bone marrow biopsies. The goal is to understand the molecular mechanisms behind mastocytosis to improve future therapies. The study will also collect clinical data and biological specimens for further research.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with mastocytosis.

How similar studies have gone: While this study focuses on specific growth factors in mastocytosis, similar studies have shown promise in understanding mast cell biology and related conditions.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Hirsh D Komarow, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
  • Study coordinator: Hye Jeong C Bolan, R.N.
  • Email: bolanhy@mail.nih.gov
  • Phone: (301) 594-1233

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Different forms of IgE in health and disease.

    We will test whether different forms of IgE in the blood differ between healthy adults and people with allergies, chronic spontaneous urticaria, recent anaphylaxis, mastocytosis, hereditary alpha tryptasemia, X‑linked agammaglobulinemia, or those undergoing venom/medication desensitization.

    Recruiting KU Leuven · Leuven, Vlaams-Brabant · NCT07328178

  • Budoprutug for adults with immune thrombocytopenia (ITP)

    This trial will test whether two IV doses of budoprutug are safe and can help raise platelet counts in adults with ITP who still have platelets under 30,000/µL after prior treatment.

    Recruiting at 18 sites Phase 1/2 Climb Bio, Inc. · Plovdiv and 19 other locations · NCT07043946

  • Finding causes of allergic reactions during and after surgery

    This project tests whether measuring tryptase levels and doing skin tests can find the cause of suspected allergic reactions during or after surgery for patients aged 2 and older.

    Recruiting at 5 sites Peking University First Hospital · Beijing, Beijing Municipality and 5 other locations · NCT06793163

  • Registry for Rare Diseases

    This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

    Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

  • Registry for patients with mastocytosis and hypertryptasemia

    This study is collecting information and samples from patients with mastocytosis and high tryptase levels at the University Hospital of Zurich to better understand their conditions and improve treatment.

    Recruiting University of Zurich · Zurich · NCT06466889

  • Exploring the role of sclerostin in bone disease related to mastocytosis

    This study is trying to see how levels of a protein called sclerostin affect bone health in adults with mastocytosis compared to healthy volunteers.

    Recruiting Medical University of Lublin · Lublin, Lublin Voivodeship · NCT06440148

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.