The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    nct04942080
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04942080
Recruitment Status : Recruiting
First Posted : June 28, 2021
Last Update Posted : November 3, 2022
Sponsor:
Collaborator:
Ligue contre le cancer, France
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date  ICMJE June 9, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date November 3, 2022
Actual Study Start Date  ICMJE October 28, 2021
Estimated Primary Completion Date April 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021)		 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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)		 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). [ Time Frame: 3 years follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
Official Title  ICMJE 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Myeloproliferative Neoplasm
  • Essential Thrombocythemia
  • Primary Myelofibrosis, Prefibrotic Stage
  • Primary Myelofibrosis, Fibrotic Stage
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: CALRSUIVI cohort
Intervention: Biological: CALR allele burden quantification
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021)		 260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2026
Estimated Primary Completion Date April 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laurane COTTIN, Doctor +33 2 41 35 53 53 Laurane.Cottin@chu-angers.fr
Contact: Emma BLANCHET +33 2 41 35 63 38 EmBlanchet@chu-angers.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04942080
Other Study ID Numbers  ICMJE 49RC21_0156
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Angers
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Angers
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ligue contre le cancer, France
Investigators  ICMJE Not Provided
PRS Account University Hospital, Angers
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP