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French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia (CARMEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877706
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.

Condition or disease Intervention/treatment
Immune Thrombocytopenia Autoimmune Hemolytic Anemia Other: no specific intervention

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
Study Start Date : June 2013
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Immune thrombocytopenia (ITP) and AIHA [ Time Frame: Baseline ]
    Number of new cases

  2. Natural evolution and events [ Time Frame: Baseline and follow-up ]
    Disease duration. Description of bleeding, infection, thrombosis events


Secondary Outcome Measures :
  1. Response [ Time Frame: 15 years ]
    platelet count >30 G/L and no bleeding

  2. Complete rate [ Time Frame: 15 years ]
    platelet count >30 G/L and no bleeding

  3. Treatment lines [ Time Frame: 15 years ]
    % of patients with each treatment by line of treatments

  4. Adverse drug reactions [ Time Frame: 15 years ]
    % of patients with adverse drug reaction reported by investigators

  5. Bleeding [ Time Frame: 15 years ]
    % of patients with bleeding during follow-up

  6. Rescue treatment [ Time Frame: 15 years ]
    % of patients with any treatment added during the exposure of ongoing treatment

  7. Adherence to ITP management guidelines. [ Time Frame: 15 years ]
    Percentage of patients who benefitted from the recommended examinations to detect secondary ITP and the percentage of patients who benefitted from the recommended first-line and second line treatments

  8. Events [ Time Frame: 15 years ]
    % of patients with other events of interest like cancer, death, infection, thrombosis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multicentric adult ITP and AIHA case recording in France, selected in centers of the French Referral Autoimmune Cytopenia Network. Both secondary and tertiary (referral) centers are participating (N=44).
Criteria

Inclusion Criteria:

  • adult patients (18+ year-old)
  • newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria:

- opposition to data collection

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877706


Contacts
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Contact: Moulis Guillaume, MD PhD moulis.g@chu-toulouse.fr
Contact: Johanne Germain, PhD johanne.germain@inserm.fr

Locations
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France
Service de Médecine Interne Recruiting
Toulouse, France, 31000
Contact: Moulis Guillaume, MD, PhD       moulis.g@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Moulis Guillaume, MD PhD University Hopsital Toulouse
More Information
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Additional Information:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02877706    
Other Study ID Numbers: RC31/12/0386
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Registry
Additional relevant MeSH terms:
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Anemia
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Blood Platelet Disorders
Purpura, Thrombocytopenic
 Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations