A New Blood Score for Myelofibrosis Staging

NCT ID: NCT06177366

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-02-01

Brief Summary

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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

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Conditions

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Myeloproliferative Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Blood sampling

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood sampling

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Nelly Bosselut, Dr

Role: CONTACT

Phone: +33142499404

Email: [email protected]

Jérôme Lambert, Pr

Role: CONTACT

Phone: +33142499742

Email: [email protected]

Other Identifiers

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APHP231007

Identifier Type: -

Identifier Source: org_study_id