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ClinicalTrials.gov ID

NCT04942080

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

260Estimated

Last Update Posted

Mar 6, 2026Actual

Start Date

Oct 28, 2021Actual

Primary Completion Date

Apr 28, 2027Estimated

Completion Date

Apr 28, 2030Estimated

Official Title

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

Brief Summary

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

Detailed 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).

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

• CALR allele burden quantification

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, AngersOTHER_GOV

Collaborators

Ligue contre le cancer, FranceOTHER

olivier.herault@univ-tours.fr+332 47 47 47 21