A New Blood Score for Myelofibrosis Staging (FIBROMOELLE)

December 11, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with MPN who need a bone marrow biopsy during the management of the disease
Diagnostic test: Blood sampling
Blood samples will be collected at diagnosis, in the same time as BOM is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve
Time Frame: 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.
At diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients
Time Frame: Up to 2 years
Number of patients initially classify as essential thrombocythemia and refile with primitive myelofibosis diagnosis.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP231007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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