A New Blood Score for Myelofibrosis Staging

NCT06177366 | Unknown

• 1 other identifier: APHP231007
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients

  Up to 2 years

Study Arms (1)

Adults with MPN who need a bone marrow biopsy during the management of the disease

Diagnostic Test: Blood sampling

Interventions

Blood sampling DIAGNOSTIC_TEST

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

Adults with MPN who need a bone marrow biopsy during the management of the disease

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with MPN who need a bone marrow biopsy during the management of the disease

You may qualify if:

• Age \> 18 years
• Diagnosis of BCR::ABL1 negative MPN according to WHO criteria classification
• Indication for bone marrow biopsy
• Non opposition
• Social security affiliation

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Nelly Bosselut, Dr

CONTACT

+33142499404; nelly.bosselut@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12