Description and Prognostic Evaluation of Four Biological Parameters of Blast Cells in Adult Acute Lymphoblastic Leukemia

This study is currently recruiting participants.

Verified by University Hospital, Angers, September 2005

First Received: September 12, 2005 Last Updated: October 27, 2005 History of Changes

Sponsor:	University Hospital, Angers
Collaborator:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT00188084

Purpose

Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients:

A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.
The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by Western Blot analysis.

The comparison between these parameters, and main haematological data, will be followed by a prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete remission, and survival.

Combination of the studied parameters will allow to appreciate a clonal diversity. This will help to predict, at diagnosis, high probability of resistance to treatment.

Condition	Intervention
Adult Acute Lymphoblastic Leukemia	Procedure: DNA Index Procedure: S-Phase% Procedure: CD45 expression Procedure: P16 metabolic way

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Analysis of Four Biological Parameters at Diagnosis of Adult Acute Lymphoblastic Leukaemia: DNA Index, Percentage of Cells in S-Phase, CD45 Fluorescence Index, and Protein P16: Prognostic Study in Patients Enrolled in a Multicentric Trial

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Estimated Enrollment:	400
Study Start Date:	November 2003
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	15 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All GRAALL 2003 and 2005 enrolled patients with available frozen blast cells

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188084

Contacts

Contact: Agnès F CHASSEVENT, PhD

33-(0)2-41-35-27-00

a.chassevent@unimedia.fr

Locations

France
CRLCC Centre Paul Papin	Recruiting
Angers, France, 49933
Contact: Agnès F CHASSEVENT, PhD 33-(0)2-41-35-27-00 a.chassevent@unimedia.fr
Sub-Investigator: Mathilde HUNAULT-BERGER, MD,PhD
Sub-Investigator: Martine FFrench, MD,PhD
Sub-Investigator: Marina Lafage-Pochitaloff, MD,PhD
Sub-Investigator: Françoise HUGUET, MD

Sponsors and Collaborators

University Hospital, Angers

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Investigators

Principal Investigator:

Laurence M Baranger, MD

University Hospital, Angers

More Information

No publications provided

Study ID Numbers:	PHRC03-02, GOELAMS 271-003
Study First Received:	September 12, 2005
Last Updated:	October 27, 2005
ClinicalTrials.gov Identifier:	NCT00188084 History of Changes
Health Authority:	France: Ministry of Health

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders

Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 25, 2009