Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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).
- - patient with another active hematological disease or cancer at the time of diagnosis, - person subject to legal protection scheme or incapable of giving consent.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital, Angers|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Myeloproliferative Neoplasm, Essential Thrombocythemia, Primary Myelofibrosis, Prefibrotic Stage, Primary Myelofibrosis, Fibrotic Stage|
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).
Experimental: CALRSUIVI cohort
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
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Laurane COTTIN, Doctor
For additional contact information, you can also visit the trial on clinicaltrials.gov.