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

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ClinicalTrials.gov Identifier: NCT00188084
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : October 28, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


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

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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
Study Start Date : November 2003
Estimated Study Completion Date : September 2005


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
French Innovative Leukemia Organisation
Investigators
Principal Investigator: Laurence M Baranger, MD University Hospital, Angers
More Information

ClinicalTrials.gov Identifier: NCT00188084     History of Changes
Other Study ID Numbers: PHRC03-02
GOELAMS 271-003
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 28, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases