A New Blood Score for Myelofibrosis Staging

Myeloproliferative Neoplasm Clinical Trial

— FIBROMOELLE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177366
• Other study ID #: APHP231007
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: December 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nelly Bosselut, Dr
• Phone: +33142499404
• Email: nelly.bosselut[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Primary Myelofibrosis

Intervention

Diagnostic Test:
• Blood sampling
Blood samples will be collected at diagnosis, in the same time as BOM is performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve	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	Number of patients	Number of patients initially classify as essential thrombocythemia and refile with primitive myelofibosis diagnosis.	Up to 2 years