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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188084
First Posted: September 16, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
French Innovative Leukemia Organisation
Information provided by:
University Hospital, Angers
  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:

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

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

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 Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: December 9, 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