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

Sponsor
University Hospital, Angers
Study ID
NCT04942080
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CALR allele burden quantification — BIOLOGICAL
    * 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

Study Details

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

Key Dates

First listed
Jun 28, 2021
Start date
Oct 28, 2021
Status verified
Mar 2026
Primary completion
Apr 28, 2027
Completion
Apr 28, 2030

Study Design

Enrollment
260 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CALRSUIVI cohort

Primary Outcome Measure

For each disease, Hazard Ratio of the different trajectories of CALR allele burden to explain the time to onset of disease progression by the clinicobiological score. [ Time Frame: 3 years follow-up ]

Central Contacts

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