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

This study is currently recruiting participants.
Study NCT00188084.   Last updated on October 27, 2005.   Information provided by University Hospital, Angers

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Descriptive Information Fields
Brief Title † Description and Prognostic Evaluation of Four Biological Parameters of Blast Cells in Adult Acute Lymphoblastic Leukemia
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
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:

  1. 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.
  2. 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 † Observational
Study Design † Natural History, Longitudinal, Defined Population, Prospective Study
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Adult Acute Lymphoblastic Leukemia
Intervention † Procedure: DNA Index
Procedure: S-Phase%
Procedure: CD45 expression
Procedure: P16 metabolic way
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 400
Start Date † November 2003
Completion Date September 2005
Eligibility Criteria †

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 No
Contacts ††
Contact: Agnès F CHASSEVENT, PhD     33-(0)2-41-35-27-00     a.chassevent@unimedia.fr    
Location Countries † France
Administrative Information Fields
NCT ID † NCT00188084
Organization ID PHRC03-02
Secondary IDs †† GOELAMS 271-003
Study Sponsor † University Hospital, Angers
Collaborators †† Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators †
Principal Investigator:     Laurence M Baranger, MD     University Hospital, Angers    
Information Provided By University Hospital, Angers
Verification Date September 2005
First Received Date † September 12, 2005
Last Updated Date October 27, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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