Immune System DiseasesCHISNCT05969821
Clonal Hematopoiesis of Immunological Significance
An observational study of Immune System Diseases and Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune System Diseases, Autoimmune Diseases, Inflammation
- What is being tested?
- observational cohort study
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Sep 2045
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The research concerns : * patients whose inflammatory disease without or with haemopathy is already known when the cohort is set up, and for whom data will be collected retrospectively and then prospectively * incident cases identified after the cohort was set up.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
AP-HP, Service de médecine interne, Hôpital Saint Antoine
Paris, 75012
Arsène MEKINIAN, MD PhD, +33 (0)1 49 28 23 92, arsene.mekinian@aphp.fr
About this study
Official title: Immuno-inflammatory Manifestations With or Without Clonal Hematopoiesis: Ambispective Cohort Study
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.
Read the detailed description
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.
- Conditions
- Immune System Diseases, Autoimmune Diseases, Inflammation, Autoinflammatory Diseases, Vexas Syndrome, Hematopoiesis Clonal
- Being tested
- observational cohort study
- Keywords
- Inflammation, Autoinflammatory Diseases, Vexas syndrome, Autoimmune Diseases, Clonal Hematopoiesis of Indeterminate Potential, Myelodysplastic-Myeloproliferative Diseases, Lymphoproliferative Disorders, Monoclonal Gammopathy of Undetermined Significance
- Medical subject headings
- Immune System Diseases, Autoimmune Diseases, Inflammation, VEXAS syndrome, Hematologic Diseases, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelomonocytic, Juvenile, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational cohort studyOther
observational cohort study
| Study group | Role | What they receive |
|---|---|---|
| Dysimmune manifestations with or without clonal hematopoiesis | Dysimmune manifestations with or without clonal hematopoiesis Receives: Other: observational cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dysimmune manifestations associated with hematological disorders
Number of new cases
Measured: Baseline
Secondary outcomes (17)
VEXAS syndrome
Number of patients with VEXAS syndrome
Measured: 10 years
Dysimmune manifestations other than VEXAS syndrome
Number of patients with dysimmune manifestations other than VEXAS syndrome
Measured: 10 years
Myeloid hemopathy
Number of patients with myeloid hemopathy
Measured: 10 years
Lymphoid hemopathy
Number of patients with lymphoid hemopathy
Measured: 10 years
Clonal hematopoiesis of undeterminate potential
Number of patients with clonal hematopoiesis of undeterminate potential
Measured: 10 years
Skin involvement
Number of patients with skin involvement
Measured: 10 years
Musculoskeletal involvement
Number of patients with musculoskeletal involvement
Measured: 10 years
Ocular involvement
Number of patients with ocular involvement
Measured: 10 years
Vascular involvement
Number of patients with vascular involvement
Measured: 10 years
Neurological involvement
Number of patients with neurological involvement
Measured: 10 years
Digestive system involvement
Number of patients with digestive system involvement
Measured: 10 years
Cardiac involvement
Number of patients with cardiac involvement
Measured: 10 years
Pulmonary involvement
Number of patients with pulmonary involvement
Measured: 10 years
Renal involvement
Number of patients with renal involvement
Measured: 10 years
Therapeutic interventions received
Type and duration of therapeutic interventions received
Measured: 10 years
Progression to acute myeloid leukemia
Number of patients who progressed to acute myeloid leukemia
Measured: 10 years
Overall mortality
Overall mortality rate from all causes
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study startApr 2026 (estimated)
- Primary completionApr 2036 (estimated)
- Study completionSep 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France, Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)
- Responsible party
- Sponsor
- Investigators
- Arsene MEKINIAN, MD PhD, Principal investigator, Service de médecine interne, Hôpital Saint Antoine, APHP, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969821
- Sponsor's protocol ID
- APHP231600
- Acronym
- CHIS
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-inflammatory Manifestations With or Without Clonal Hematopoiesis: Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT05969821
- Acronym / sponsor ID
- CHIS / APHP231600
- Conditions
- Immune System Diseases, Autoimmune Diseases, Inflammation, Autoinflammatory Diseases, Vexas Syndrome, Hematopoiesis Clonal
- Keywords
- Inflammation, Autoinflammatory Diseases, Vexas syndrome, Autoimmune Diseases, Clonal Hematopoiesis of Indeterminate Potential, Myelodysplastic-Myeloproliferative Diseases, Lymphoproliferative Disorders, Monoclonal Gammopathy of Undetermined Significance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sorbonne University, Institut National de la Santé Et de la Recherche Médicale, France, Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2036 (estimated)
- Study completion
- Sep 2045 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysimmune manifestations with or without clonal hematopoiesis | – | Other: observational cohort studyDysimmune manifestations with or without clonal hematopoiesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research concerns : * patients whose inflammatory disease without or with haemopathy is already known when the cohort is set up, and for whom data will be collected retrospectively and then prospectively * incident cases identified after the cohort was set up.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational cohort studyobservational cohort study | Other | Dysimmune manifestations with or without clonal hematopoiesis |
Primary outcome
Incidence of dysimmune manifestations associated with hematological disorders
Time frame: Baseline
Number of new cases
17 secondary outcomes
VEXAS syndrome
Time frame: 10 years
Dysimmune manifestations other than VEXAS syndrome
Time frame: 10 years
Myeloid hemopathy
Time frame: 10 years
Lymphoid hemopathy
Time frame: 10 years
Clonal hematopoiesis of undeterminate potential
Time frame: 10 years
Skin involvement
Time frame: 10 years
Musculoskeletal involvement
Time frame: 10 years
Ocular involvement
Time frame: 10 years
Vascular involvement
Time frame: 10 years
Neurological involvement
Time frame: 10 years
Digestive system involvement
Time frame: 10 years
Cardiac involvement
Time frame: 10 years
Pulmonary involvement
Time frame: 10 years
Renal involvement
Time frame: 10 years
Therapeutic interventions received
Time frame: 10 years
Progression to acute myeloid leukemia
Time frame: 10 years
Overall mortality
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arsene MEKINIAN, MD PhD principal investigator
Service de médecine interne, Hôpital Saint Antoine, APHP, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune System Diseases and Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arsene MEKINIAN, MD PhD (+33149282392, arsene.mekinian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dysimmune manifestations associated with hematological disorders (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.