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

July 27, 2023 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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).

Description

Inclusion Criteria:

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

Exclusion criteria:

- opposition to data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Immune thrombocytopenia (ITP) and AIHA
Time Frame: Baseline
Number of new cases
Baseline
Natural evolution and events
Time Frame: Baseline and follow-up
Disease duration. Description of bleeding, infection, thrombosis events
Baseline and follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response
Time Frame: 15 years
platelet count >30 G/L and no bleeding
15 years
Complete rate
Time Frame: 15 years
platelet count >30 G/L and no bleeding
15 years
Treatment lines
Time Frame: 15 years
% of patients with each treatment by line of treatments
15 years
Adverse drug reactions
Time Frame: 15 years
% of patients with adverse drug reaction reported by investigators
15 years
Bleeding
Time Frame: 15 years
% of patients with bleeding during follow-up
15 years
Rescue treatment
Time Frame: 15 years
% of patients with any treatment added during the exposure of ongoing treatment
15 years
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
15 years
Events
Time Frame: 15 years
% of patients with other events of interest like cancer, death, infection, thrombosis
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Moulis Guillaume, MD PhD, University Hopsital Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

July 2, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/12/0386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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