Immune ThrombocytopeniaOPTIMISTNCT06556888
Observatory of Immunological Thrombopenic Purpura in the Brest Region
An observational study of Immune Thrombocytopenia, run by University Hospital, Brest at 1 site in France.
Trial summary
Database of patients with ITP, diagnosed, treated and followed in the Brest University Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immune Thrombocytopenia
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2019to 30 Nov 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with ITP diagnosed, treated or followed at UHB
Who may be able to join
- Patients with ITP agree to participate
Who cannot join
- Other thrombocythopenia other than ITP
- Patients Under guardianship
- Patients without national social security
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hematology Department - Institute of Oncology and Hematology, University Hospital of Brest
Brest, Brittany Region, 29609
Veronique Kouassi, 33298223333, veronique.kouassi@chu-brest.fr
Jean-Christophe Ianotto, MD, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Immune Thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What is being measured
The primary outcome is the main question the study is designed to answer.
Description chronicity
Identification/description of risk factors of chronicity
Measured: 1 year
Description treatment responses
Identification/ description of risk factors of bad responses
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start20 Jun 2019
- Primary completion19 Nov 2020
- Study completion30 Nov 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Pan-Petesch, MD, Principal investigator, UHB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556888
- Sponsor's protocol ID
- 29BRC19.0089
- Acronym
- OPTIMIST
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2020
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Immunological Thrombopenic Purpura in the Brest Region: Descriptive and Comparative Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06556888
- Acronym / sponsor ID
- OPTIMIST / 29BRC19.0089
- Conditions
- Immune Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 30 Nov 2039 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Database of patients with ITP, diagnosed, treated and followed in the Brest University Hospital.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with ITP diagnosed, treated or followed at UHB
Key inclusion criteria (1 listed)
- Patients with ITP agree to participate
Key exclusion criteria (3 listed)
- Other thrombocythopenia other than ITP
- Patients Under guardianship
- Patients without national social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description chronicity
Time frame: 1 year
Identification/description of risk factors of chronicity
Description treatment responses
Time frame: 1 year
Identification/ description of risk factors of bad responses
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitte Pan-Petesch, MD principal investigator
UHB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigitte Pan-Petesch, MD (33298223650, brigitte.pan-petesch@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description chronicity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.