RecruitingNot ApplicableNCT04942080

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

Sponsor

University Hospital, Angers

Enrollment

260 participants

Start Date

Oct 28, 2021

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria2

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

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Interventions

BIOLOGICALCALR allele burden quantification

* DNA extraction from blood sample for CALR mutation quantification (fragment analysis) * at diagnosis and follow-up (inclusion period: 3 years) * max 1 sample/year * secondary outcome: mutational landscape by Next Generation Sequencing (NGS) analysis at diagnosis