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Not yet recruitingNCT05969821CHISUpdated Mar 23, 2026

Clonal Hematopoiesis of Immunological Significance

An observational study in Immune System Diseases, Autoimmune Diseases and Inflammation, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • Immune System Diseases
  • Autoimmune Diseases
  • Inflammation
  • Autoinflammatory Diseases
  • Vexas Syndrome
  • Hematopoiesis Clonal
  • Clonal Hematopoiesis of Indeterminate Potential
  • Hematologic Diseases
  • Myelodysplastic-Myeloproliferative Diseases
  • Leukemia Myelomonocytic Chronic
  • Myelodysplastic Syndromes
  • Myeloproliferative Disorders
  • Lymphoproliferative Disorders
  • Lymphoma
  • Leukemia
  • Monoclonal Gammopathy of Undetermined Significance

Keywords

  • Inflammation
  • Autoinflammatory Diseases
  • Vexas syndrome
  • Autoimmune Diseases
  • Clonal Hematopoiesis of Indeterminate Potential
  • Myelodysplastic-Myeloproliferative Diseases
  • Lymphoproliferative Disorders
  • Monoclonal Gammopathy of Undetermined Significance
03

In context

Immune System Diseases

427 studies on the registry are indexed under Immune System Diseases; 86 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 246 across 88 observational studies indexed under Immune System Diseases.

Browse Immune System Diseases studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
5,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Dysimmune manifestations with or without clonal hematopoiesis

    Dysimmune manifestations with or without clonal hematopoiesis

    Other: observational cohort study

Interventions

  • Otherobservational cohort study

    observational cohort study

06

What researchers measure

Primary outcomes

  1. Incidence of dysimmune manifestations associated with hematological disorders

    Number of new cases

    Time frame: Baseline

Secondary outcomes

  1. VEXAS syndrome

    Number of patients with VEXAS syndrome

    Time frame: 10 years

  2. Dysimmune manifestations other than VEXAS syndrome

    Number of patients with dysimmune manifestations other than VEXAS syndrome

    Time frame: 10 years

  3. Myeloid hemopathy

    Number of patients with myeloid hemopathy

    Time frame: 10 years

  4. Lymphoid hemopathy

    Number of patients with lymphoid hemopathy

    Time frame: 10 years

  5. Clonal hematopoiesis of undeterminate potential

    Number of patients with clonal hematopoiesis of undeterminate potential

    Time frame: 10 years

  6. Skin involvement

    Number of patients with skin involvement

    Time frame: 10 years

  7. Musculoskeletal involvement

    Number of patients with musculoskeletal involvement

    Time frame: 10 years

  8. Ocular involvement

    Number of patients with ocular involvement

    Time frame: 10 years

  9. Vascular involvement

    Number of patients with vascular involvement

    Time frame: 10 years

  10. Neurological involvement

    Number of patients with neurological involvement

    Time frame: 10 years

  11. Digestive system involvement

    Number of patients with digestive system involvement

    Time frame: 10 years

  12. Cardiac involvement

    Number of patients with cardiac involvement

    Time frame: 10 years

  13. Pulmonary involvement

    Number of patients with pulmonary involvement

    Time frame: 10 years

  14. Renal involvement

    Number of patients with renal involvement

    Time frame: 10 years

  15. Therapeutic interventions received

    Type and duration of therapeutic interventions received

    Time frame: 10 years

  16. Progression to acute myeloid leukemia

    Number of patients who progressed to acute myeloid leukemia

    Time frame: 10 years

  17. Overall mortality

    Overall mortality rate from all causes

    Time frame: 10 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Apr 2036, 120 months later.

Of 45 non-industry observational studies under Immune System Diseases, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 16. This study's planned 120 months is above that.

Counting every sponsor, half of 47 studies reached it within 48 months; a quarter within 17.

Immune System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2023
First posted
Aug 1, 2023
StartEst.
Apr 2026
Primary completionEst.
Apr 2036
CompletionEst.
Sep 2045
Last update
Mar 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05969821
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)
Responsible party
Sponsor
First posted
Aug 1, 2023
Start date
Apr 2026 (estimated)
Primary completion
Apr 2036 (estimated)
Completion
Sep 2045 (estimated)
Last update
Mar 23, 2026

Study contacts

Arsene MEKINIAN, MD PhD
Contact
arsene.mekinian@aphp.fr
+33149282392
Arsene MEKINIAN, MD PhD
principal investigator · Service de médecine interne, Hôpital Saint Antoine, APHP, Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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