Evaluating CALR Allele Burden in Myeloproliferative Neoplasms
Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI)
This study is trying to see if tracking a specific genetic change in the blood can help doctors understand how myeloproliferative neoplasms progress in patients over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 10 sites (Angers and 9 other locations) |
| Trial ID | NCT04942080 on ClinicalTrials.gov |
What this trial studies
This study investigates the significance of monitoring CALR allele burden as a molecular marker for disease progression in patients with CALR-mutated myeloproliferative neoplasms (MPNs). It aims to analyze a multicenter cohort of 260 patients, collecting blood samples at diagnosis and annually for three years to quantify CALR allele burden. The study will also assess a clinicobiological score to determine disease progression in patients with Essential Thrombocythemia and Myelofibrosis, building on previous findings from a local study that highlighted the prognostic value of CALR mutation quantification.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosed CALR-mutated myeloproliferative neoplasm and available samples from diagnosis.
Not a fit: Patients with another active hematological disease or cancer at the time of diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for monitoring disease progression in patients with CALR-mutated MPNs.
How similar studies have performed: Previous studies have indicated the prognostic impact of CALR mutation quantification, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Angers and 9 other locations
- CHU Angers — Angers, France (Recruiting)
- Chu Bordeaux — Bordeaux, France (Recruiting)
- Chu Brest — Brest, France (Recruiting)
- Ch Cholet — Cholet, France (Recruiting)
- Ch Le Mans — Le Mans, France (Recruiting)
- Ch Morlaix — Morlaix, France (Recruiting)
- AP-HP Henri Mondor — Paris, France (Recruiting)
- Chu Poitiers — Poitiers, France (Recruiting)
- Ch Quimper — Quimper, France (Recruiting)
- Chu Tours — Tours, France (Recruiting)
Study contacts
- Study coordinator: Laurane COTTIN, Doctor
- Email: Laurane.Cottin@chu-angers.fr
- Phone: +33 2 41 35 53 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.