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Trial Title:
Clonal Hematopoiesis of Immunological Significance
NCT ID:
NCT05969821
Condition:
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
Conditions: Official terms:
Leukemia
Myelodysplastic Syndromes
Lymphoproliferative Disorders
Hematologic Diseases
Myeloproliferative Disorders
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Myelodysplastic-Myeloproliferative Diseases
Autoimmune Diseases
Immune System Diseases
Syndrome
Inflammation
Conditions: 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 [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
observational cohort study
Description:
observational cohort study
Arm group label:
Dysimmune manifestations with or without clonal hematopoiesis
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2023
Completion date:
September 2043
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
Sorbonne University
Agency class:
Other
Collaborator:
Agency:
Institut National de la Santé Et de la Recherche Médicale, France
Agency class:
Other
Collaborator:
Agency:
Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO)
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05969821
