A New Blood Score for Myelofibrosis Staging (FIBROMOELLE)
Development of a Blood Score for Myelofibrosis Staging in BCR:ABL1 Negative Myeloproliferative Neoplasms Using Bone Marrow Biopsy as a Gold Standard
BCR:ABL1 negative myeloproliferative neoplasms (MPN) include three entities: polycythemia vera, essential thrombocythemia and primitive myelofibrosis. Myelofibrosis is a life-threatening complication in MPN with several therapeutic options including hematopoietic stem cell transplantation (HSCT) which remains the only curative treatment. Bone marrow biopsy with histological analysis allows myelofibrosis identification and staging. However, it is an invasive procedure that remains painful and provides potential haemorrhagic complications. Development of non-invasive biomarkers for myelofibrosis staging could help to better stratify this disease, better define patients' prognosis and lead to optimal cares.
The main aim of this work is to develop a non-invasive blood score including several biomarkers for myelofibrosis staging in MPN using bone marrow biopsy as a gold standard.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jérôme Lambert, Pr
- Phone Number: +33142499742
- Email: jerome.lambert@u-paris.fr
Study Contact Backup
- Name: Nelly Bosselut, Dr
- Phone Number: +33142499404
- Email: nelly.bosselut@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Diagnosis of BCR::ABL1 negative MPN according to WHO criteria classification
- Indication for bone marrow biopsy
- Non opposition
- Social security affiliation
Exclusion Criteria:
- Non-contributory biopsy
- AML transformation
- Organ fibrosis (liver, lung, kidney…)
- HSCT
- Chronic inflammatory disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults with MPN who need a bone marrow biopsy during the management of the disease
|
Blood samples will be collected at diagnosis, in the same time as BOM is performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area under the curve
Time Frame: At diagnosis
|
Area under the receiver operating characteristic (AUROC) curve of the blood score to discriminate absence or mild fibrosis from advanced fibrosis, using histological analysis as a gold standard.
|
At diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients
Time Frame: Up to 2 years
|
Number of patients initially classify as essential thrombocythemia and refile with primitive myelofibosis diagnosis.
|
Up to 2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP231007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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