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Sequential Analysis in Patients With an Hemopathy

Sequential Analysis in Patients With an Hemopathy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02260739
Acronym
S-HEMO
Enrollment
246
Registered
2014-10-09
Start date
2014-01-31
Completion date
2026-01-31
Last updated
2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemopathy

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.

Interventions

OTHERBlood samples

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of new genetic alterationsAt baseline and then every 6 months up to 24 monthsIdentification of new genetic alterations in patients with hematological malignancies by next generation sequencing using blood samples

Secondary

MeasureTime frameDescription
Sequential analysis of the malignant clonesAt baseline and 12 months after inclusionSequential analysis of the malignant clones for each patient included in the trial using genetic markers

Countries

France

Contacts

Primary ContactVincent RIBRAG, MD
vincent.ribrag@gustaveroussy.fr0142114507
Backup ContactThibaud MOTREFF, MD
thibaud.motreff@gustaveroussy.fr0142116643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026