Myeloproliferative DisordersCARPEDIEMNCT06481345
Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele (CARPEDIEM)
An observational study of Myeloproliferative Disorders, run by University Hospital, Brest at 1 site in France.
Trial summary
Retrospective study assessing the impact of IDH1/2, SRSF2 or SF3B1 mutations on event free survival of MPN patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorders
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients followed by hematologists of the French Intergroup of MPN
Who may be able to join
- Patients with MPN diagnosis
- Mutation in IDH1/2, SRSF2 or SF3B1
Who cannot join
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele
Retrospective study assessing the impact of IDH1/2, SRSF2 or SF3B1 mutations on event free survival of MPN patients
Read the detailed description
Patients with a diagnosis of MPN and a mutation of IDH1/2, SRSF2 or SF3B1 will be included. Clinical and biological characterisation at diagnosis, as well as evlution will be recorded. Event free survival will be assessed in each group (event = thrombosis, transformation to mylofibrosis/acute leukemia, death).
- Conditions
- Myeloproliferative Disorders
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MPN patients with IDH1/2 mutation | Not described | |
| MPN patients with SRSF2 mutation | Not described | |
| MPN patients with SF3B1 mutation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start25 Jun 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisordersStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481345
- Sponsor's protocol ID
- 29BRC24.0154 - CARPEDIEM
- Acronym
- CARPEDIEM
- Status last verified
- Apr 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele
- ClinicalTrials.gov ID
- NCT06481345
- Acronym / sponsor ID
- CARPEDIEM / 29BRC24.0154 - CARPEDIEM
- Conditions
- Myeloproliferative Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Jul 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.
Retrospective study assessing the impact of IDH1/2, SRSF2 or SF3B1 mutations on event free survival of MPN patients
Detailed description
Patients with a diagnosis of MPN and a mutation of IDH1/2, SRSF2 or SF3B1 will be included. Clinical and biological characterisation at diagnosis, as well as evlution will be recorded. Event free survival will be assessed in each group (event = thrombosis, transformation to mylofibrosis/acute leukemia, death).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MPN patients with IDH1/2 mutation | – | – |
| MPN patients with SRSF2 mutation | – | – |
| MPN patients with SF3B1 mutation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients followed by hematologists of the French Intergroup of MPN
Key inclusion criteria (2 listed)
- Patients with MPN diagnosis
- Mutation in IDH1/2, SRSF2 or SF3B1
Key exclusion criteria (1 listed)
- Unable to consent
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
Event free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Myeloproliferative Disorders, 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: 3 years). 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 1 Jul 2024.