- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06556888
Observatory of Immunological Thrombopenic Purpura in the Brest Region (OPTIMIST)
August 13, 2024 updated by: University Hospital, Brest
Observatory of Immunological Thrombopenic Purpura in the Brest Region: Descriptive and Comparative Cross-sectional Study
Database of patients with ITP, diagnosed, treated and followed in the Brest University Hospital.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Creation of a global clinical and biological database for all patients diagnosed, treated and followed for ITP in the University Hospital of Brest.
UHB is the regional reference center (competence center) on hemorrhagic diseases.
Dr Pan-Petesch, who is responsible of the local competence center, is affiliated to the national sector of auto-immune cytopenias CERECAI-MARIH).
Study Type
Observational
Enrollment (Estimated)
500
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
- Name: Brigitte Pan-Petesch, MD
- Phone Number: 33298223650
- Email: brigitte.pan-petesch@chu-brest.fr
Study Contact Backup
- Name: Veronique Kouassi
- Phone Number: 33298223333
- Email: veronique.kouassi@chu-brest.fr
Study Locations
-
-
Bretagne
-
Brest, Bretagne, France, 29609
- Recruiting
- Hematology Department - Institute of Oncology and Hematology, University Hospital of Brest
-
Contact:
- Veronique Kouassi
- Phone Number: 33298223333
- Email: veronique.kouassi@chu-brest.fr
-
Sub-Investigator:
- Jean-Christophe Ianotto, MD, PhD
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients with ITP diagnosed, treated or followed at UHB
Description
Inclusion Criteria:
- Patients with ITP agree to participate
Exclusion Criteria:
- Other thrombocythopenia other than ITP
- Patients Under guardianship
- Patients without national social security
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description chronicity
Time Frame: 1 year
|
Identification/description of risk factors of chronicity
|
1 year
|
|
Description treatment responses
Time Frame: 1 year
|
Identification/ description of risk factors of bad responses
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brigitte Pan-Petesch, MD, UHB
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 (Actual)
June 20, 2019
Primary Completion (Actual)
November 19, 2020
Study Completion (Estimated)
November 30, 2039
Study Registration Dates
First Submitted
November 19, 2020
First Submitted That Met QC Criteria
August 13, 2024
First Posted (Actual)
August 16, 2024
Study Record Updates
Last Update Posted (Actual)
August 16, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Cytopenia
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- 29BRC19.0089
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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