A New Blood Score for Myelofibrosis Staging

Development of a Blood Score for Myelofibrosis Staging in BCR:ABL1 Negative Myeloproliferative Neoplasms Using Bone Marrow Biopsy as a Gold Standard

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06177366

Acronym

FIBROMOELLE

Enrollment

120

Registered

2023-12-20

Start date

2024-02-01

Completion date

2026-02-01

Last updated

2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloproliferative Neoplasm

Brief summary

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.

Interventions

DIAGNOSTIC_TESTBlood sampling

Blood samples will be collected at diagnosis, in the same time as BOM is performed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve	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.

Secondary

Measure	Time frame	Description
Number of patients	Up to 2 years	Number of patients initially classify as essential thrombocythemia and refile with primitive myelofibosis diagnosis.

Contacts

Primary ContactNelly Bosselut, Dr

nelly.bosselut@aphp.fr+33142499404

Backup ContactJérôme Lambert, Pr

jerome.lambert@u-paris.fr+33142499742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026