Sequential Analysis in Patients With an Hemopathy

Hemopathy Clinical Trial

— S-HEMO  

Official title:

Sequential Analysis in Patients With an Hemopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02260739
• Other study ID #: 2013-A00208-37
• Secondary ID: 2013/2031
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2014
• Last updated: August 7, 2017
• Start date: January 2014
• Est. completion date: January 2026

Study information

• Verified date: August 2017
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Vincent RIBRAG, MD
• Phone: 0142114507
• Email: vincent.ribrag[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: January 2026
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemopathy

Intervention

Other:
• Blood samples

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sequential analysis of the malignant clones	Sequential analysis of the malignant clones for each patient included in the trial using genetic markers	At baseline and 12 months after inclusion