A New Blood Score for Myelofibrosis Staging

Not yet recruiting

• Conditions: Myeloproliferative Neoplasm
• Interventions: Diagnostic Test: Blood sampling

• Registration Number: NCT06177366
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Study Start: 2024-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

• Non-contributory biopsy
• AML transformation
• Organ fibrosis (liver, lung, kidney...)
• HSCT
• Chronic inflammatory disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with MPN who need a bone marrow biopsy during the management of the disease	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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