NCT02260739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

5 years

First QC Date

September 16, 2014

Last Update Submit

August 7, 2017

Conditions

Hemopathy

Outcome Measures

Primary Outcomes (1)

  • Identification of new genetic alterations

    Identification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples

    At baseline and then every 6 months up to 24 months

Secondary Outcomes (1)

  • Sequential analysis of the malignant clones

    At baseline and 12 months after inclusion

Study Arms (3)

chronic myelomonocytic leukemia

OTHER

Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)

Other: Blood samples

essential thrombocytemia

OTHER

Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)

Other: Blood samples

myelofibrosis

OTHER

Three cohorts will be investigated: ET (essential thrombocythemia), IMF and secondary MF (myelofibrosis) and CMML (chronic myelomonocytic leukemia)

Other: Blood samples

Interventions

Blood samplesOTHER
chronic myelomonocytic leukemiaessential thrombocytemiamyelofibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Vincent RIBRAG, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Central Study Contacts

Vincent RIBRAG, MD

CONTACT

0142114507vincent.ribrag@gustaveroussy.fr

Thibaud MOTREFF, MD

CONTACT

0142116643thibaud.motreff@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

October 9, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2026

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

FR(1)