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NCT06177366 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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