Clonal Hematopoiesis of Immunological Significance (CHIS)

March 19, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75012
        • AP-HP, Service de médecine interne, Hôpital Saint Antoine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dysimmune manifestations with or without clonal hematopoiesis
Other: observational cohort study
observational cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dysimmune manifestations associated with hematological disorders
Time Frame: Baseline
Number of new cases
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VEXAS syndrome
Time Frame: 10 years
Number of patients with VEXAS syndrome
10 years
Dysimmune manifestations other than VEXAS syndrome
Time Frame: 10 years
Number of patients with dysimmune manifestations other than VEXAS syndrome
10 years
Myeloid hemopathy
Time Frame: 10 years
Number of patients with myeloid hemopathy
10 years
Lymphoid hemopathy
Time Frame: 10 years
Number of patients with lymphoid hemopathy
10 years
Clonal hematopoiesis of undeterminate potential
Time Frame: 10 years
Number of patients with clonal hematopoiesis of undeterminate potential
10 years
Skin involvement
Time Frame: 10 years
Number of patients with skin involvement
10 years
Musculoskeletal involvement
Time Frame: 10 years
Number of patients with musculoskeletal involvement
10 years
Ocular involvement
Time Frame: 10 years
Number of patients with ocular involvement
10 years
Vascular involvement
Time Frame: 10 years
Number of patients with vascular involvement
10 years
Neurological involvement
Time Frame: 10 years
Number of patients with neurological involvement
10 years
Digestive system involvement
Time Frame: 10 years
Number of patients with digestive system involvement
10 years
Cardiac involvement
Time Frame: 10 years
Number of patients with cardiac involvement
10 years
Pulmonary involvement
Time Frame: 10 years
Number of patients with pulmonary involvement
10 years
Renal involvement
Time Frame: 10 years
Number of patients with renal involvement
10 years
Therapeutic interventions received
Time Frame: 10 years
Type and duration of therapeutic interventions received
10 years
Progression to acute myeloid leukemia
Time Frame: 10 years
Number of patients who progressed to acute myeloid leukemia
10 years
Overall mortality
Time Frame: 10 years
Overall mortality rate from all causes
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Sorbonne University
Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)

Investigators

  • Principal Investigator: Arsene MEKINIAN, MD PhD, Service de médecine interne, Hôpital Saint Antoine, APHP, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2036

Study Completion (Estimated)

September 1, 2045

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe