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

NCT ID: NCT03869476

Last Updated: 2024-12-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2024-01-30

Brief Summary

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

Detailed Description

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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

Conditions

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Myeloproliferative Disorder Essential Thrombocythemia Primary Myelofibrosis, Prefibrotic Stage Primary Myelofibrosis, Fibrotic Stage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BioscoreSMP cohort

Group Type EXPERIMENTAL

Non-invasive diagnosis score

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Non-invasive diagnosis score

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Angers

Angers, , France

Site Status

CHRU de Brest - Hôpital Morvan

Brest, , France

Site Status

Countries

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France

Other Identifiers

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49RC18_0153_1

Identifier Type: -

Identifier Source: org_study_id