Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Disorders
CTIM3
1 other identifier
observational
300
1 country
2
Brief Summary
Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
2 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
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 30, 2016
CompletedFirst Posted
Study publicly available on registry
July 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMarch 29, 2018
March 1, 2018
3 years
June 30, 2016
March 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
cumulative incidence or progression
inclusion
Secondary Outcomes (4)
Disease phenotype according to WHO classification
3 years
Treatment response/resistance
3 years
Mean life-years gained
3 years
Quality-adjusted life years gained
3 years
Eligibility Criteria
Philadelphia-negative Myeloproliferative neoplasms (MPN)
You may qualify if:
- Patients suffering from Myeloproliferative neoplasms (MPN) diagnosed between 2005 and 2013
- Sample DNA diagnostics available: 500 mcg
- Untreated or treated with hydroxyurea, ruxolitinib, alpha interferon,
- Patient has given his(her) own consent for the use of the sample for research on the pathology and genetic analyzes
You may not qualify if:
- Refused to participate
- Patient treated with another molecule that hydroxyurea, ruxolitinib, or alpha interferon
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre d'Investigations Cliniques
Paris, 75010, France
Centre d'Investigations Cliniques
Paris, 75010, France
Biospecimen
Molecular markers include mutations in JAK2, MPL, TET2, LNK, CBL, IDH1/2, DNMT3A, EZH2, ASXL1, SF3B1, SRSF2, NRAS/KRAS, and TP53
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2016
First Posted
July 6, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
March 29, 2018
Record last verified: 2018-03