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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 27, 2005

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00188084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal, Defined Population, Prospective Study

Condition ^ICMJE

Adult Acute Lymphoblastic Leukemia

Intervention ^ICMJE

Procedure: DNA Index
Procedure: S-Phase%
Procedure: CD45 expression
Procedure: P16 metabolic way

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

400

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

None

Gender

Both

Ages

15 Years to 59 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Agnès F CHASSEVENT, PhD

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

a.chassevent@unimedia.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00188084

Responsible Party

Study ID Numbers ^ICMJE

PHRC03-02, GOELAMS 271-003

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Laurence M Baranger, MD

University Hospital, Angers

Information Provided By

University Hospital, Angers

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP