Clonal Hematopoiesis of Immunological Significance

NCT ID: NCT05969821

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2045-09-30

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Dysimmune manifestations with or without clonal hematopoiesis

Dysimmune manifestations with or without clonal hematopoiesis

observational cohort study

Intervention Type OTHER

observational cohort study

Interventions

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observational cohort study

observational cohort study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorbonne University

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arsene MEKINIAN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Service de médecine interne, Hôpital Saint Antoine, APHP, Paris

Central Contacts

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Arsene MEKINIAN, MD PhD

Role: CONTACT

+33149282392

Other Identifiers

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APHP231600

Identifier Type: -

Identifier Source: org_study_id

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