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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00188084
First received: September 12, 2005
Last updated: October 27, 2005
Last verified: September 2005
  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
Time Perspective: Longitudinal
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on July 20, 2014