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Scientists study mast cells to unlock mastocytosis mysteries

NCT ID NCT00044122

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 17, 2026 · Updated 25 times

Summary

This study collects bone marrow and blood samples from up to 600 people with mastocytosis, a condition where too many mast cells cause symptoms like itching and bone pain. Researchers will study what makes these cells grow and survive. The goal is to learn more about the disease, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this research succeeds, it could point toward new treatments that control mast cell growth in mastocytosis.
What could go wrong
This is an observational study, not a treatment trial. It is early-stage research that may not directly lead to therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2002

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

primary clinical

Ages

1 day to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

bone marrow disorder mastocytosis monoclonal gammopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone marrow Mastocytosis Monoclonal Tryptase

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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