Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Disorders

Myeloproliferative Neoplasms Clinical Trial

— CTIM3  

Official title:

Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Neoplasms (CTIM3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823210
• Other study ID #: TRANSLA13-140
• Status: Recruiting
• First received: June 30, 2016
• Last updated: March 27, 2018
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Refused to participate

• Patient treated with another molecule that hydroxyurea, ruxolitinib, or alpha interferon

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasms
• Neoplasms

Locations

Country	Name	City	State
France	Centre d'Investigations Cliniques	Paris
France	Centre d'Investigations Cliniques	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative incidence or progression		inclusion
Secondary	Disease phenotype according to WHO classification	polycythemia vera, essential thrombocythemia, primary myelofibrosis, and others	3 years
Secondary	Treatment response/resistance		3 years
Secondary	Mean life-years gained	The analysis will take into consideration the cost of testing, but also the costs of different treatment options with or without testing, and other disease-related costs dependent on treatment	3 years
Secondary	Quality-adjusted life years gained		3 years