NCT04005638

Brief Summary

The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units ("Bedside to the Bench Strategy"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress92%
Feb 2019Jan 2027

Study Start

First participant enrolled

February 2, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

7.9 years

First QC Date

June 17, 2019

Last Update Submit

March 25, 2025

Conditions

Keywords

Biological collection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA)

    At baseline (Day 0)

Study Arms (1)

Autoimmune Cytopenia

Biological: blood sampleBiological: urine sample

Interventions

blood sampleBIOLOGICAL

45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Autoimmune Cytopenia
urine sampleBIOLOGICAL

12 ml

Autoimmune Cytopenia

Eligibility Criteria

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

Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).

You may qualify if:

  • Patients over 16 years old.
  • Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).
  • Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

  • Positivity for HIV, Hepatitis C or B virus.
  • Pregnant or lactating woman.
  • Patient undergoing treatment for autoimmune cytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de médecine interne

Pessac, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and urine sample

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicAnemia, Hemolytic, Autoimmune

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsAnemia, HemolyticAnemia

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-François VIALLARD, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François VIALLARD, Prof

CONTACT

Isabelle RAYMOND, Pharm

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

July 2, 2019

Study Start

February 2, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations