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Blood test revolution: pinpointing the cause of swelling attacks

NCT ID NCT06210698

Diagnosis Sponsor: Foundation For Rare Disease Research Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study evaluates whether new blood tests can more accurately diagnose the cause of recurrent angioedema—a condition causing severe swelling—compared to current tests. Researchers will compare novel diagnostic assays with traditional ones in 600 people aged 12 and older who have angioedema or related conditions. The goal is to develop a reliable, affordable lab test that can identify the specific type of angioedema, aiding in better management and treatment.

What this could mean

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

Active substance
Venipuncture (blood draw) for diagnostic testing
What this could lead to
If successful, this could lead to a more accurate and affordable blood test to diagnose different types of angioedema, improving patient care.
What could go wrong
This is an early-stage diagnostic study; new tests may not prove more effective than existing ones, and results may not apply to all patient groups.

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 600 people

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

Started

Jan 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The collection of medical history and peripheral blood (venipuncture) to perform multiple diagnostic assays from patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. Healthy volunteers will not have a medical history of angioedema.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: * Understand and sign the informed consent form before starting any study procedure. * Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian). * Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA. * Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy. Exclusion Criteria: * Minor: 11 years of age or younger. * Cannot read or understand the informed consent form and instructions. * Unable to perform the peripheral blood sample collection. * Taking medications contraindicated for testing. * History of excessive bleeding after phlebotomy, e.g. Hemophilia. * Contraindication due to other health-related issues.

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Conditions

The condition(s) this trial relates to.

angioedema C1 inhibitor deficiency hereditary angioedema indolent systemic mastocytosis mastocytosis Mastocytosis, Systemic renin-angiotensin-aldosterone system-blocker-induced angioedema systemic mastocytosis urticaria

As listed by the trial registrant

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

ACE inhibitor-induced angioedema Angioedema Angioedemas, hereditary C1 inhibitor deficiency Indolent systemic mastocytosis Mastocytosis Systemic mastocytoses Urticaria

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

  • Institute for Asthma and Allergy Clinical Research

    RECRUITING

    Wheaton, Maryland, 20902, United States

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