Pilot Study for the Development of a Diagnostic Score to Differentiate Myeloproliferative Neoplasms.

  • STATUS
    Recruiting
  • End date
    Jun 23, 2023
  • participants needed
    130
  • sponsor
    University Hospital, Angers
Updated on 23 January 2021

Summary

Prospective study for the development of a non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.

Description

The diagnostic criteria for myeloproliferative neoplasia have recently been revised in the WHO 2016 classification, which now recognizes a new entity between essential thrombocythemia (TE) and overt myelofibrosis (or primary myelofibrosis): prefibrotic myelofibrosis. Prefibrotic myelofibrosis patients seem to have a poorer prognosis compared to essential thrombocythemia in term of overall survival and myelofibrotic evolution. The dichotomy between these diseases is based on the bone marrow biopsy evaluation and is challenging with a lack of reproducibility showed in the literature.

This study aims to develop a diagnostic non-invasive score for differentiating prefibrotic myelofibrosis from essential thrombocytosis and overt myelofibrosis.

The parameters studied are :

  • spleen fibrosis by elastography
  • plasma cytokines levels
  • mutationnal landscape by NGS
  • CD34 circulating cells

Bone marrow biopsy were reviewed by 2 anatomopathologists. Number of patients to be enrolled : 130

Details
Condition MYELOPROLIFERATIVE DISORDER, ESSENTIAL THROMBOCYTHEMIA, Myeloproliferative Neoplasms, myeloproliferative neoplasm, myeloproliferative disorders, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage
Treatment Non-invasive diagnosis score
Clinical Study IdentifierNCT03869476
SponsorUniversity Hospital, Angers
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 99 yrs?
Gender: Male or Female
Do you have any of these conditions: myeloproliferative neoplasm or ESSENTIAL THROMBOCYTHEMIA or Myeloproliferative Neoplasms or Primary Myelofibrosis, Prefibrotic Stage or MYELOPROLIFERA...?
Adult (18 years of age or older) with the diagnosis of essential thrombocytosis, prefibrotic myelofibrosis or overt myelofibrosis according to WHO 2016 criteria
Patient who has not received specific treatment for neoplasms
Patient who has signed the consent to participate in the study
Patient who has consented to be included in the "Malignant Haemopathies" collection at the University Hospital of Angers or Brest and for whom the samples necessary for the study are available in the biocollection

Exclusion Criteria

Patient with another hematologic neoplasm or progressive cancer at the time of diagnosis
Patient with a diagnosis of secondary myelofibrosis
Pregnant or breastfeeding woman
Person prived of liberty by judicial or administrative decision
Person subject to a legal protection measure
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