Sequential Analysis in Patients With an Hemopathy

Not Applicable

Recruiting

• Conditions: Hemopathy
• Interventions: Other: Blood samples

• Registration Number: NCT02260739
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

Recent advances in hematology clearly illustrate that the simple "clonal" nature of various hematological malignancies may not really reflect the reality of malignant cells natural expansion. This has been nicely illustrated in recent works in AML for example where subclones coexists in the same patient at the same time, but could also differentially expand over time because of effects of therapeutics intervention, but also by oncogenic spontaneous events (1).

These observations have been done recently because of next generation sequencing that allows to discriminate in the same tumor samples, different subclones and to analyse the clonal architecture. Sequential analyses could help us to identify the first oncogenic event and to correlate disease progression to the emergence of subclones.

For all these reasons it is of a major interest to precisely understand the architecture of the clone in MPNs, especially to understand which is the initiating event and how from this initial event the clone develops.

In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN, but may favor the development of other malignant hemopathies.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08
• Primary Completion: 2019-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• Patients with a malignant hematological disease.
• Signed written informed consent
• Age and Sex : men and women aged 18 years or older
• Patients affiliated to a social security system

Exclusion Criteria

• Patients protected by law, in accordance with Articles L1121-L1121-5 to 8 of the Code of Public Health.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chronic myelomonocytic leukemia	Blood samples	Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
myelofibrosis	Blood samples	Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)
essential thrombocytemia	Blood samples	Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)

Primary Outcome Measures

Name	Time	Method
Identification of new genetic alterations	At baseline and then every 6 months up to 24 months	Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples

Secondary Outcome Measures

Name	Time	Method
Sequential analysis of the malignant clones	At baseline and 12 months after inclusion	Sequential analysis of the malignant clones for each patient included in the trial using genetic markers

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val de Marne, France