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Trial record 1 of 1 for:    NCT03869476
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Pilot Study for the Development of a Diagnostic Score to Differentiate Myeloproliferative Neoplasms. (BioScoreSMP)

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ClinicalTrials.gov Identifier: NCT03869476
Recruitment Status : Unknown
Verified September 2019 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 11, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Myeloproliferative Disorder Essential Thrombocythemia Primary Myelofibrosis, Prefibrotic Stage Primary Myelofibrosis, Fibrotic Stage Diagnostic Test: Non-invasive diagnosis score Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study for the Development of a Non-invasive Diagnostic Score to Differentiate Between Essential Thrombocythemia, Premyelofibrosis and Myelofibrosis
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869476


Contacts
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Contact: Damien Luque Paz, Pharm.D. 0241355590 ext 0033 damien.luquepaz@chu-angers.fr
Contact: Corentin Orvain, M.D. 0241356451 ext 0033 corentin.orvain@chu-angers.fr

Locations
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France
Chu Angers Recruiting
Angers, France, 49000
Contact: Damien Luque Paz    0241355353 ext 0033    damien.luquepaz@chu-angers.fr   
Principal Investigator: Damien Luque Paz         
Sub-Investigator: Corentin Orvain         
CHRU de Brest - Hôpital Morvan Not yet recruiting
Brest, France, 29100
Contact: Jean-Christophe Ianotto    0298223786 ext 0033    jean-christophe.ianotto@chu-brest.fr   
Principal Investigator: Jean-Christophe Ianotto         
Sub-Investigator: Eric Lippert         
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03869476    
Other Study ID Numbers: 49RC18_0153_1
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data of study protocol, Statiscal analysis plan and the infromed consent form will be made available after the study completion
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available within 1 year of study completion
Access Criteria: Data access requests will be reviewed and requestors will be required to sign a data acess agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Myelofibrosis
Thrombocytosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
 Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders