Clonal Hematopoiesis of Immunological Significance

Lymphoma Clinical Trial

— CHIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969821
• Other study ID #: APHP221121
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2043

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Arsene MEKINIAN, MD PhD
• Phone: +33149282392
• Email: arsene.mekinian[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: September 2043
• Est. primary completion date: September 2043
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoinflammatory Diseases
• Clonal Hematopoiesis of Indeterminate Potential
• Hematologic Diseases
• Immune System Diseases
• Inflammation
• Leukemia
• Lymphoma
• Lymphoproliferative Disorders
• Monoclonal Gammopathy of Undetermined Significance
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myeloproliferative Disorders
• Paraproteinemias
• Syndrome

Intervention

Other:
• observational cohort study
observational cohort study

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Club MINHEMON (MEDECINE INTERNE, HEMATO ET ONCO), Institut National de la Santé Et de la Recherche Médicale, France, Sorbonne University

Outcome

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