Examining factors that affect mast cell growth in mastocytosis
Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells
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 type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 1 Day to 80 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00044122 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 0 to 80 with a confirmed diagnosis of mastocytosis.
Not a fit: Patients with severe anemia or other conditions that contraindicate participation may not benefit from this study.
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 performed: While this study focuses on specific growth factors in mastocytosis, similar studies have shown promise in understanding mast cell biology and related conditions.
Eligibility criteria
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 less than 8 g/dL, hematocrit less than 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.