Clonal Hematopoiesis of Immunological Significance

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05969821
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arsene MEKINIAN, MD PhD
Principal Investigator Affiliation	Service de médecine interne, Hôpital Saint Antoine, APHP, Paris
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being 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

Additional Details

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.

Arms & Interventions

Arms

: Dysimmune manifestations with or without clonal hematopoiesis

Dysimmune manifestations with or without clonal hematopoiesis

Interventions

Other: - observational cohort study

observational cohort study

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Arsene MEKINIAN, MD PhD

[email protected]

+33149282392

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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