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

Primary Purpose

Myeloproliferative Disorder, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Non-invasive diagnosis score

About this trial

This is an interventional diagnostic trial for Myeloproliferative Disorder

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Chu AngersRecruiting
CHRU de Brest - Hôpital Morvan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BioscoreSMP cohort

Arm Description

Outcomes

Primary Outcome Measures

WHO 2016 criteria for prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis

Assessment of the non-invasive diagnostic score against the WHO diagnosis

Secondary Outcome Measures

Full Information

NCT ID

NCT03869476

First Posted

March 6, 2019

Last Updated

September 21, 2023

Sponsor

University Hospital, Angers

1. Study Identification

Unique Protocol Identification Number

NCT03869476

Brief Title

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

Acronym

BioScoreSMP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 30, 2019 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BioscoreSMP cohort

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

Non-invasive diagnosis score

Intervention Description

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

Primary Outcome Measure Information:

Title

WHO 2016 criteria for prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis

Description

Assessment of the non-invasive diagnostic score against the WHO diagnosis

Time Frame

At the time of diagnosis : disease classification

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Damien Luque Paz, Pharm.D.

Phone

0241355590

Ext

0033

damien.luquepaz@chu-angers.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Corentin Orvain, M.D.

Phone

0241356451

Ext

0033

corentin.orvain@chu-angers.fr

Facility Information:

Facility Name

Chu Angers

City

Angers

ZIP/Postal Code

49000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Damien Luque Paz

Phone

0241355353

Ext

0033

damien.luquepaz@chu-angers.fr

First Name & Middle Initial & Last Name & Degree

Damien Luque Paz

First Name & Middle Initial & Last Name & Degree

Corentin Orvain

Facility Name

CHRU de Brest - Hôpital Morvan

City

Brest

ZIP/Postal Code

29100

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Christophe Ianotto

Phone

0298223786

Ext

0033

jean-christophe.ianotto@chu-brest.fr

First Name & Middle Initial & Last Name & Degree

Jean-Christophe Ianotto

First Name & Middle Initial & Last Name & Degree

Eric Lippert

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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