CHIS: Clonal Hematopoiesis of Immunological Significance

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05969821

Collaborator

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

1,000

Enrollment

240

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas syndrome.

Condition or Disease	Intervention/Treatment	Phase
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	Other: observational cohort study

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

National Cohort of Patients With Dysimmune Manifestations With or Without Clonal Hematopoiesis

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2043

Anticipated Study Completion Date :

Sep 1, 2043

Arms and Interventions

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

Arm

Intervention/Treatment

Dysimmune manifestations with or without clonal hematopoiesis

Other: observational cohort study

observational cohort study

Outcome Measures

Primary Outcome Measures

clinical, biological, physiopathological, therapeutic and prognostic characteristics of dysimmune manifestations associated with myeloid/lymphoid haemopathies [Day 1]
clinical, biological, physiopathological, therapeutic and prognostic characteristics of dysimmune manifestations associated with myeloid/lymphoid haemopathies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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