Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)

University Hospital, Angers

Status

Enrolling

Conditions

Primary Myelofibrosis, Prefibrotic Stage

Primary Myelofibrosis, Fibrotic Stage

Myeloproliferative Neoplasm

Essential Thrombocythemia

Treatments

Biological: CALR allele burden quantification

Study type

Interventional

Funder types

Other

Identifiers

NCT04942080

49RC21_0156

Details and patient eligibility

About

Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.

Full description

A first local study on 45 patients showed the prognostic impact of CALR mutation quantification in follow-up, independently of the European LeukemiaNet (ELN) prognostic score validated in this group of patients.

This study aims to evaluate a multicenter cohort of 260 patients, including all types of CALR-mutated MPNs and several follow-up samples, to model the temporal evolution of CALR allele burden.

Blood of MPN patients will be collected, at the time of diagnosis and for 3 years (max 1 sample/year), for the quantification of the CALR allele burden. During follow-up, a clinicobiological score to define the progression or not of the disease for each patient will be evaluated in Essential Thrombocythemia (ET) and MyeloFibrosis (MF).

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adults (age ≥18 years),
affiliated to the national social security system,
with CALR mutated myeloproliferative neoplasm diagnosed between 2006 - 2020,
for which at least one sample is available at the time of diagnosis or before cytoreductive treatment,
who signed the consent to participate in the study,
included, or consenting to be included, in the national clinical-biological database of France Intergroupe Syndrome Myéloprolifératifs (FIM).

Exclusion criteria

patient with another active hematological disease or cancer at the time of diagnosis,
person subject to legal protection scheme or incapable of giving consent.