ClinicalTrials.gov record NCT05969821
Clonal Hematopoiesis of Immunological Significance
Immuno-inflammatory Manifestations With or Without Clonal Hematopoiesis: Ambispective Cohort Study
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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.
Ambispective (retrospective + prospective) international observational cohort following patients up to 10 years. It aims to record and describe immune‑inflammatory manifestations that occur with or without clonal hematopoiesis or other blood diseases, their treatments, genetics, and outcomes. Data will feed a multicentre database to support future research.
What it is studying. The study seeks to describe how often people with clonal hematopoiesis or haematological diseases have immuno‑inflammatory problems and how those problems relate to clinical features, genetic mutations (including VEXAS), treatments, progression, and outcomes.
What the researchers hope to learn. To measure the incidence and types of immuno‑inflammatory manifestations in people with clonal hematopoiesis or haematological disease; to describe clinical and biological presentations (including VEXAS); to identify genetic mutations linked to manifestations; to assess progression (including to acute myeloid leukemia) and mortality; to compare treatments received; and to build a multicentre database to inform future therapeutic trials and risk stratification.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- observational cohort study
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age >=18 years old;
- Confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease;
- Presence or absence of myeloid or lymphoid blood disease according to World Health Organization (WHO) classification
Exclusion criteria
- Persons benefiting from special protection: adults under guardianship and curatorship;
- People hospitalized without their consent and not protected by law; persons deprived of liberty;
- Persons not affiliated to the social security system
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
The clinical spectrum of dysimmune manifestations associated with blood diseases is wide. The pathophysiology of these manifestations is not well understood and their management is poorly codified. This observational cohort aims to list the different clinical pictures, the therapeutic management and the prognosis of patients according to the type of dysimmune manifestations and the type of hemopathy. We wish to have an inventory of the demographic, genetic, clinical and evolutionary data of patients with an inflammatory manifestation associated or not with a myeloid or lymphoid hemopathy. This will make it possible to establish quantitative data on the morbidity and mortality of these rare diseases and to propose therapeutic trials for the most serious patients. This is an International, multicentre, observational cohort study with retrospective and prospective components (ambispective). The primary objective is to describe the incidence of immuno-inflammatory manifestations in patients with clonal hematopoiesis or a haematological disease. The secondary objectives are as follows:
- To describe the clinical and biological presentation of immuno-inflammatory manifestations according to the type of underlying haematological disease or clonal hematopoiesis;
- To describe the clinical and biological presentation of VEXAS syndrome and its association with other haematological diseases;
- To study the relationship between giant cell arteritis and clonal hematopoiesis;
- To specify clinical symptoms according to the genetic mutations identified;
- To define the main genetic mutations associated with these manifestations;
- To identify patients eligible for different therapeutic trials;
- To assess the characteristics of associated haematological diseases;
- To compare the effectiveness of immunomodulatory and antitumour treatments according to the type of immuno-inflammatory manifestation and type of underlying haematological disease or clonal hematopoiesis;
- To study the profile of patients eligible for stem cell transplantation;
- To study mortality in patients followed for an inflammatory disease with or without haematological disease/clonal hematopoiesis;
- To explore the natural history of patients over a 10-year follow-up in order to better characterise long-term complications;
- To build a multicentre reference database enabling cross-sectional and longitudinal analyses to guide future therapeutic strategies;
- To establish correlations between clinical, biological and molecular characteristics in order to better stratify risk and adapt patient management.
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.
This is an observational study: researchers will collect past medical information for people already diagnosed and will follow participants forward for up to 10 years. Data collected will include clinical history, biological and genetic information, treatments received, and clinical outcomes; this will come from medical records and periodic follow-up. There are no study-assigned treatments; participation involves data collection and follow-up rather than experimental procedures. The registry does not list any specific invasive study procedures.
How the study is structured. An international, multicentre, ambispective observational cohort. Researchers will collect past medical data and follow participants prospectively for up to 10 years to record diagnoses, genetics, treatments received, complications, and survival. No experimental treatments are given as part of the study.
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 VEXAS syndrome
Important dates
- Study start
- April 2026 (estimated)
- Primary completion
- April 2036 (estimated)
- Study completion
- September 2045 (estimated)
- Target enrollment
- 5000 participants (estimated)
- Last updated on registry
- Mar 23, 2026
- 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
- Sorbonne University
- Institut National de la Santé Et de la Recherche Médicale, France
- Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)
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.
- Arsene MEKINIAN, MD PhD 📞 +33149282392 ✉ arsene.mekinian@aphp.fr
Participating sites (1)
- AP-HP, Service de médecine interne, Hôpital Saint Antoine
Paris, 75012 · France
- Arsène MEKINIAN, MD PhD · +33 (0)1 49 28 23 92 · arsene.mekinian@aphp.fr
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.
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- natural history
- A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
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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