ClinicalTrials.gov
ClinicalTrials.gov Menu

Autoimmune Cytopenias : Midi-Pyrenees Registry (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 : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
CARMEN is a clinical registry of all incident adult Immune thrombocytopenia (ITP) and Autoimmune Hemolytic anemia (AIHA) patients in the Midi-Pyrenees region (South of France). It is aimed at describing ITP and AIHA clinical features, assessing the risk-benefit ratio of second-line treatments (SLTs) and adherence to guidelines for ITP and AIHA management.

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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Autoimmune Cytopenias : Midi-Pyrenees Registry
Study Start Date : June 2013
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023





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

  2. Bleeding symptoms [ Time Frame: Baseline and each year ]
    Description of bleeding symptoms : number of bleeding symptoms


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 10 years ]

    Efficacy outcomes response rate, complete response rate. Effectiveness outcomes are overall and cause specific mortality, absence of need of second-line ITP treatment, withdrawal of corticosteroids and quality of life (SF-36 scale).

    Safety outcomes are adverse drug reactions.


  2. Adherence to ITP management guidelines. [ Time Frame: 10 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

  3. Bleeding symptoms [ Time Frame: Each year during 10 years ]
    Description of bleeding symptoms : number of bleeding symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Adult ITP and AIHA case recording in the Midi-Pyrénées region, South of France. ITP patients are treated by internal medicine and hematology practitioners actually spread in one tertiary hospital (located in Toulouse and including one hematology and six internal medicine departments) and 14 peripheral public or private hospitals. All these practitioners take actively part to the network of the Midi-Pyrénées Competence Center for Autoimmune Cytopenias.
Criteria

Inclusion Criteria:

  • More than 18 years
  • newly diagnosed ITP or AIHA

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
Contact: Moulis Guillaume, MD PhD moulis.g@chu-toulouse.fr
Contact: Adoue Daniel, MD adoue.d@chu-toulouse.fr

Locations
France
Service de Médecine Interne Recruiting
Toulouse, France, 31000
Contact: Moulis Guillaume, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Moulis Guillaume, MD PhD University Hopsital Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02877706     History of Changes
Other Study ID Numbers: 12 386 02
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Anemia