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

September 21, 2023 updated by: University Hospital, Angers

Pilot Study for the Development of a Non-invasive Diagnostic Score to Differentiate Between Essential Thrombocythemia, Premyelofibrosis and Myelofibrosis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

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

Study Locations

  • France
      • Angers, France, 49000
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Damien Luque Paz
        • Sub-Investigator:
          • Corentin Orvain
      • Brest, France, 29100
        • Not yet recruiting
        • CHRU de Brest - Hôpital Morvan
        • Contact:
        • Principal Investigator:
          • Jean-Christophe Ianotto
        • Sub-Investigator:
          • Eric Lippert

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

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioscoreSMP cohort
Diagnostic test: Non-invasive diagnosis score
  • spleen fibrosis by elastography
  • plasma cytokines levels
  • mutationnal landscape by NGS
  • CD34 circulating cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHO 2016 criteria for prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis
Time Frame: At the time of diagnosis : disease classification
Assessment of the non-invasive diagnostic score against the WHO diagnosis
At the time of diagnosis : disease classification

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

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 (Actual)

July 30, 2019

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC18_0153_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data of study protocol, Statiscal analysis plan and the infromed consent form will be made available after the study completion

IPD Sharing Time Frame

Data will be available within 1 year of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed and requestors will be required to sign a data acess agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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