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Leukemia Cell Cultures for Research of New Anti-Cancer Therapies

Primary Purpose

Acute Leukaemia

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sampling

Bone marrow aspiration

About this trial

This is an interventional basic science trial for Acute Leukaemia focused on measuring Leukaemia, Blood and marrow cells culture, Cell growth, Cell differentiation

Eligibility Criteria

28 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service d'Hématologie et d'OncologieRecruiting
Service de Pédiaterie - Hôpital de HautepierreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00993538

First Posted

October 9, 2009

Last Updated

August 29, 2011

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00993538

Brief Title

Leukemia Cell Cultures for Research of New Anti-Cancer Therapies

Official Title

Leukemia Cell Cultures for Research of New Anti-cancer Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukaemia

Keywords

Leukaemia, Blood and marrow cells culture, Cell growth, Cell differentiation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Blood sampling

Intervention Type

Procedure

Intervention Name(s)

Bone marrow aspiration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Raoul Herbrecht, MD

Phone

3.33.88.12.83.79

Raoul.herbrecht@chru-strasbourg.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick lutz, MD

Phone

3.33.88.12.80.90

Patrick.lutz@chru-strasbourg.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raoul Herbrecht, MD

Organizational Affiliation

Département d'Hématologie et d'Oncologie-hôpital de Hautepierre Strasbourg, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service d'Hématologie et d'Oncologie

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raoul Herbrecht, MD

Phone

3.33.88.12.83.79

Raoul.herbrecht@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Raoul Herbrecht, MD

First Name & Middle Initial & Last Name & Degree

Cécile Fohrer, MD

First Name & Middle Initial & Last Name & Degree

Luc Fornecker, MD

First Name & Middle Initial & Last Name & Degree

Bruno Lioure, MD

First Name & Middle Initial & Last Name & Degree

Karin Bilger, MD

Facility Name

Service de Pédiaterie - Hôpital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick Lutz, MD

Phone

3.33.88.12.80.90

Patrick.lutz@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Patrick Lutz, MD

First Name & Middle Initial & Last Name & Degree

Natacha Entz-Werle, MD

12. IPD Sharing Statement

Learn more about this trial

Leukemia Cell Cultures for Research of New Anti-Cancer Therapies

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