Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
CALRSUIVI
1 other identifier
interventional
260
1 country
10
Brief Summary
Prospective study to evaluate the relevance of CALR allele burden monitoring as a molecular marker of disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
October 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2030
March 6, 2026
March 1, 2026
5.5 years
June 9, 2021
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Clinicobiological score : For ET, disease progression if ≥ 1 of: * leukocytosis \> 12 G/L or myelemia \> 10% or erythroblasts \> 1%, * anemia or thrombocytopenia not related to drug toxicity, * development or worsening of splenomegaly, * development of thrombocytosis (platelets \> 450 G/L) on cytoreductive therapy, * poor disease control (at least one change in therapy for reasons other than adverse events), * hematologic transformation or death related to hematologic pathology. For MF, disease progression if ≥ 1 of: * anemia \< 100 g/L, neutropenia \< 1 G/L, thrombocytopenia \< 100 G/L and/or development of general signs not previously present or recurring after improvement, * increase in leukocytosis \> 25 G/L not previously present, * appearance or aggravation of transfusion dependence, * appearance (\> 5 cm) or aggravation (\> 50%) of splenomegaly, * leukemic transformation or death related to the hematologic pathology.
3 years follow-up
Secondary Outcomes (1)
A multinomial logistic model will be performed to identify the characteristics associated with the different trajectories of CALR allele burden (pathology, treatment, additional mutations, type of CALR mutation).
3 years follow-up
Study Arms (1)
CALRSUIVI cohort
EXPERIMENTALInterventions
* 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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- patient with another active hematological disease or cancer at the time of diagnosis,
- person subject to legal protection scheme or incapable of giving consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Angerslead
- Ligue contre le cancer, Francecollaborator
Study Sites (10)
CHU Angers
Angers, France
Chu Bordeaux
Bordeaux, 33604, France
Chu Brest
Brest, 29200, France
Ch Cholet
Cholet, 49300, France
Ch Le Mans
Le Mans, 72037, France
Ch Morlaix
Morlaix, 29672, France
AP-HP Henri Mondor
Paris, 94010, France
Chu Poitiers
Poitiers, 86021, France
Ch Quimper
Quimper, 29107, France
Chu Tours
Tours, 37000, France
Related Publications (1)
Cottin L, Riou J, Orvain C, Ianotto JC, Boyer F, Renard M, Truchan-Graczyk M, Murati A, Jouanneau-Courville R, Allangba O, Mansier O, Burroni B, Rousselet MC, Quintin-Roue I, Martin A, Sadot-Lebouvier S, Delneste Y, Chretien JM, Hunault-Berger M, Blanchet O, Lippert E, Ugo V, Luque Paz D. Sequential mutational evaluation of CALR -mutated myeloproliferative neoplasms with thrombocytosis reveals an association between CALR allele burden evolution and disease progression. Br J Haematol. 2020 Mar;188(6):935-944. doi: 10.1111/bjh.16276. Epub 2019 Nov 11.
PMID: 31710700BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2021
First Posted
June 28, 2021
Study Start
October 28, 2021
Primary Completion (Estimated)
April 28, 2027
Study Completion (Estimated)
April 28, 2030
Last Updated
March 6, 2026
Record last verified: 2026-03