NCT04942080

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	CALR 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

Timeline

• Start date: 2021-10-28
• Primary completion: 2027-04-28
• Completion: 2030-04-28
• First posted: 2021-06-28
• Last updated: 2026-03-06

Locations

10 sites across 1 country: France