NCT00993538

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

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

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

First QC Date

October 9, 2009

Last Update Submit

August 29, 2011

Conditions

Acute Leukaemia

Keywords

LeukaemiaBlood and marrow cells cultureCell growthCell differentiation

Study Arms (1)

1

EXPERIMENTAL
Procedure: Blood samplingProcedure: Bone marrow aspiration

Interventions

Blood samplingPROCEDURE
1
Bone marrow aspirationPROCEDURE
1

Eligibility Criteria

Age28 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service d'Hématologie et d'Oncologie

Strasbourg, 67098, France

RECRUITING

Service de Pédiaterie - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Leukemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Raoul Herbrecht, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul Herbrecht, MD

CONTACT

3.33.88.12.83.79Raoul.herbrecht@chru-strasbourg.fr

Patrick lutz, MD

CONTACT

3.33.88.12.80.90Patrick.lutz@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

July 1, 2009

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

FR(2)