Myeloproliferative NeoplasmVYPNCT06715267
Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications (VYP)
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Brest at 1 site in France.
Trial summary
The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. Read more about this study
- Who is it for?
- Ages 0 to 30 years
- Conditions the study is for
- Myeloproliferative Neoplasm
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 1 Apr 2038
- 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 0 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with non-LMC myeloproliferative neoplasm before age 30 (Polycythemia vera, essential thrombocythemia, primary myelofibrosis, prefibrotic myelofibrosis).
Who may be able to join
- Patient diagnosed with non-LMC MPN before the age of 30 (PV or TE or MFP or PreMF) according to the 2016 WHO criteria.
- Signature of the consent form for participation in the FIMBANK project.
- Agreement to participate in the VYP study.
- Patient of legal age at the time of inclusion in VYP.
- Patient affiliated to a social security scheme
Who cannot join
- Refusal to participate by patients of full age
- Patient under legal protection (guardianship, curatorship, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications
The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. It will also make it possible to identify the biological samples (histological and molecular) available in routine laboratories, enabling teams of researchers and anatomopathologists to (re)perform certain analyses to re-evaluate diagnoses and search for hitherto unknown molecular prognostic factors.
- Conditions
- Myeloproliferative Neoplasm
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the epidemiological characteristics of the study population
Description of MPN subtypes according to age
Measured: at enrollment
Describe the mutational landscape of these MPNs
Rate of mutations JAK2/CALR/MPL
Measured: at enrollment
Secondary outcomes (3)
Describe the classical MPN (Myeloproliferative neoplasia) outcomes-1
Incidence of thrombosis
Measured: At 10 years
Describe the classical MPN outcomes-2
Incidence of myelofibrosis
Measured: At 10 years
Describe the classical MPN outcomes-3
Incidence of MDS/AML
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Apr 2023
- Primary completion1 Apr 2038 (estimated)
- Study completion1 Apr 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 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
- NCT06715267
- Sponsor's protocol ID
- 29BRC23.0018 - VYP
- Acronym
- VYP
- Status last verified
- Dec 2024
- First submitted
- 20 Aug 2024
- Last updated
- 4 Dec 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children, Adolescents and Young Adults with Myeloproliferative Neoplasia: Study of Clinico-biological Characteristics and Complications
- ClinicalTrials.gov ID
- NCT06715267
- Acronym / sponsor ID
- VYP / 29BRC23.0018 - VYP
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2038 (estimated)
- Study completion
- 1 Apr 2038 (estimated)
- First posted
- 4 Dec 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.
The creation of a national database will provide access to solid data on the diagnosis of myeloproliferative neoplasia for patients under 30, giving a true picture of their care. It will also make it possible to identify the biological samples (histological and molecular) available in routine laboratories, enabling teams of researchers and anatomopathologists to (re)perform certain analyses to re-evaluate diagnoses and search for hitherto unknown molecular prognostic factors.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with non-LMC myeloproliferative neoplasm before age 30 (Polycythemia vera, essential thrombocythemia, primary myelofibrosis, prefibrotic myelofibrosis).
Key inclusion criteria (5 listed)
- Patient diagnosed with non-LMC MPN before the age of 30 (PV or TE or MFP or PreMF) according to the 2016 WHO criteria.
- Signature of the consent form for participation in the FIMBANK project.
- Agreement to participate in the VYP study.
- Patient of legal age at the time of inclusion in VYP.
- Patient affiliated to a social security scheme
Key exclusion criteria (2 listed)
- Refusal to participate by patients of full age
- Patient under legal protection (guardianship, curatorship, etc.)
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
Describe the epidemiological characteristics of the study population
Time frame: at enrollment
Description of MPN subtypes according to age
Describe the mutational landscape of these MPNs
Time frame: at enrollment
Rate of mutations JAK2/CALR/MPL
3 secondary outcomes
Describe the classical MPN (Myeloproliferative neoplasia) outcomes-1
Time frame: At 10 years
Describe the classical MPN outcomes-2
Time frame: At 10 years
Describe the classical MPN outcomes-3
Time frame: At 10 years
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 4 Dec 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Myeloproliferative Neoplasm
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RecruitingPhase 2
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Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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.
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 Neoplasm, 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 5 inclusion and 2 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 4 Dec 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 Jean-Christophe IANOTTO (0298223786 ext. +33, jean-christophe.ianotto@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the epidemiological characteristics of the study population (time frame: at enrollment). 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 4 Dec 2024.