NCT05969821

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
235mo left

Started Apr 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Sep 2045

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2.7 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2036

Expected
9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2045

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

July 23, 2023

Last Update Submit

March 19, 2026

Conditions

Vexas SyndromeHematopoiesis ClonalClonal Hematopoiesis of Indeterminate PotentialHematologic DiseasesMyelodysplastic-Myeloproliferative DiseasesLymphoproliferative DisordersLymphomaLeukemiaMonoclonal Gammopathy of Undetermined SignificanceImmune System DiseasesAutoimmune DiseasesInflammationAutoinflammatory DiseasesLeukemia Myelomonocytic ChronicMyelodysplastic SyndromesMyeloproliferative Disorders

Keywords

InflammationAutoinflammatory DiseasesVexas syndromeAutoimmune DiseasesClonal Hematopoiesis of Indeterminate PotentialMyelodysplastic-Myeloproliferative DiseasesLymphoproliferative DisordersMonoclonal Gammopathy of Undetermined Significance

Outcome Measures

Primary Outcomes (1)

  • Incidence of dysimmune manifestations associated with hematological disorders

    Number of new cases

    Baseline

Secondary Outcomes (17)

  • VEXAS syndrome

    10 years

  • Dysimmune manifestations other than VEXAS syndrome

    10 years

  • Myeloid hemopathy

    10 years

  • Lymphoid hemopathy

    10 years

  • Clonal hematopoiesis of undeterminate potential

    10 years

  • +12 more secondary outcomes

Study Arms (1)

Dysimmune manifestations with or without clonal hematopoiesis

Dysimmune manifestations with or without clonal hematopoiesis

Other: observational cohort study

Interventions

observational cohort studyOTHER

observational cohort study

Dysimmune manifestations with or without clonal hematopoiesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Service de médecine interne, Hôpital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Immune System DiseasesAutoimmune DiseasesInflammationVEXAS syndromeHematologic DiseasesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myelomonocytic, JuvenileMyelodysplastic SyndromesMyeloproliferative DisordersLymphoproliferative DisordersLymphomaLeukemiaMonoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesImmunoproliferative DisordersHypergammaglobulinemiaBlood Protein DisordersParaproteinemias

Study Officials

  • Arsene MEKINIAN, MD PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arsene MEKINIAN, MD PhD

CONTACT

+33149282392arsene.mekinian@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2036

Study Completion (Estimated)

September 1, 2045

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)