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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00993538
Other study ID # 4452
Secondary ID
Status Recruiting
Phase N/A
First received October 9, 2009
Last updated August 29, 2011
Start date July 2009

Study information

Verified date August 2011
Source University Hospital, Strasbourg, France
Contact Raoul Herbrecht, MD
Phone 3.33.88.12.83.79
Email Raoul.herbrecht@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The main objective of this project is not only a better understanding of the human leukemic disease but also to find new anti-leukemic or improve existing ones. This study has, the following aims:

- To analyze the genetic and epigenetic regulation of the retinoic acid induced cascade which leads to the expression of TRAIL in blood cells of patients with acute leukemia. This study will be complemented by the analysis of global gene expression (DNA chips) and of the DNA methylation state, and by chromatin immunoprecipitation experiences.

- To determine the efficiency of inhibitors of enzymes responsible for the modification of chromatin (existing and new developments within the European consortium EPITRON coordinated by Dr Gronemeyer) as inducers of differentiation and / or apoptosis of leukemic blasts.

- To explore Ikaros genic and functional abnormalities (genomic deletions, mutations, abnormal transcripts and proteins) in acute leukemia. The aim is to determine if these abnormalities may play a prognosis role.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with suspected de novo or secondary or relapsed acute leukemia, requiring complementary blood test and bone marrow analysis

- Patients older or equal than 28 days

- Informed consent signed

Exclusion Criteria:

- Pregnancy

- Breastfeeding

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sampling

Bone marrow aspiration


Locations

Country Name City State
France Service d'Hématologie et d'Oncologie Strasbourg
France Service de Pédiaterie - Hôpital de Hautepierre Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

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