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

NCT03869476 | Completed DMC

• 1 other identifier: 49RC18_0153_1
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  At the time of diagnosis : disease classification

Study Arms (1)

BioscoreSMP cohort

EXPERIMENTAL

Diagnostic Test: Non-invasive diagnosis score

Interventions

Non-invasive diagnosis score DIAGNOSTIC_TEST

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

BioscoreSMP cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

Chu Angers

Angers, 49000, France

Location

CHRU de Brest - Hôpital Morvan

Brest, 29100, France

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombocythemia, Essential; Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: July 30, 2019
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

FR (2)