ClinicalTrials.gov record NCT05292768

Are Mast Cells Involved in Autoinflammatory Diseases

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Are Mast Cells Involved in Autoinflammatory Diseases

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.The registry record was last updated on Mar 23, 2022, about 4 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A prospective observational study of adults with autoinflammatory diseases and several control groups. It records symptoms, measures mast-cell mediators in blood, plasma and urine, and examines digestive and skin biopsies. The study tests whether mast cells show activation or infiltration in these conditions.

What it is studying. Whether mast cells are involved in autoinflammatory diseases by assessing clinical signs of mast cell activation, measuring mast-cell mediators (total serum tryptase and histamine) in blood/plasma/urine, and studying biopsy tissue.

What the researchers hope to learn. Determine the presence of clinical and biological markers of mast cell activation in autoinflammatory disease. Compare clinical mast-cell activation symptoms between AID patients, mastocytosis, other inflammatory diseases, and healthy controls. Identify which mast-cell mediators are associated with AID and whether they correlate with inflammation. Study mast-cell infiltration in biopsies and basophil activation in blood samples.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Autoinflammatory diseases (AID) are caused by innate immunity dysregulation. AID pathophysiology is only partly understood, especially in the case of unclassified AID. Mast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS).Our aim is to evaluate the involvement of MC in AID by assessing clinical and biological signs of MC activation and studying cutaneous and digestive biopsies.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients >18 years old with Auto-inflammatory diseases already followed up at the CeRéMAIA (french national reference center for autoinflamamtory diseases and AA amyloidosis) of Tenon hospital and included in the JIRcohorte
  • Healthy adult controls, age- and sex-matched with MAI patients, and controls with mastocytosis, an immuno-inflammatory disease.
  • Subject affiliated to or entitled to a social security scheme
  • Collection of the patient's or healthy control's non-opposition

Exclusion criteria

  • Subjects unable to answer questions or express themselves
  • Subjects who do not speak French
  • Subject deprived of liberty or under legal protection.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Autoinflammatory diseases (AID) are caused by innate immunity dysregulation and characterized by recurrent bouts of fever, frequently associated with digestive, articular or cutaneous symptoms, and sometimes ocular, auricular or neurologic inflammation. The most frequent monogenic AID is Familial Mediterranean fever (FMF). Despite recent genetic progress AID pathophysiology is only partly understood, especially in the case of unclassified AID. Mast cells (MC) are innate immune cells associated with a spectrum of disease between systemic mastocytosis and mast cell activation syndrome (MCAS). In MCAS, patients have various symptoms including abdominal pain, bloating, pruritus, flush, anxiety, fatigue, among which some are similar to those seen in patients with AID. The implication of MC has been shown in cryopyrin associated periodic syndrome (CAPS). Our hypothesis is that MC could be involved in AID pathophysiology, In order to test this hypothesis, we plan to study :

  • clinical MC activation symptoms via a standardized clinical score
  • biological MC mediators : by measuring total serum tryptase and histamine in total blood, plasma and urine
  • MC infiltration on gastro-intestinal (GI) tract and cutaneous biopsies We will compare clinical MC activation score in AID patients to patients with mastocytosis, with other inflammatory diseases, and with healthy controls.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

At an inclusion visit participants will have a clinical assessment using a standardized mast-cell activation score. They will give blood and urine samples for measurement of mast-cell mediators (total serum tryptase and histamine) and for basophilic polynuclear (basophil) activation testing. When available, existing digestive, cutaneous, or renal biopsy samples will be examined for mast cell infiltration and compared with control groups.

How the study is structured. Prospective observational cohort study. Researchers will collect clinical scores, blood/plasma/urine samples and analyze available digestive, renal and skin biopsies at inclusion (and retrospectively for some biopsies), then compare findings across patient and control groups.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

This trial is also listed on this site under cryopyrin-associated periodic syndromes.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
March 2022 (estimated)
Primary completion
October 2026 (estimated)
Study completion
October 2026 (estimated)
Target enrollment
590 participants (estimated)
Last updated on registry
Mar 23, 2022
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
  • Institut Imagine

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Service de Médecine Interne

    Paris, 75020 · France

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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