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NCT00188084 Clinical Trial

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

Adult Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00188084
Other study ID # PHRC03-02
Secondary ID GOELAMS 271-003
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated October 27, 2005
Start date November 2003
Est. completion date September 2005

Study information
Verified date September 2005
Source University Hospital, Angers
Contact Agnès F CHASSEVENT, PhD
Phone 33-(0)2-41-35-27-00
Email a.chassevent@unimedia.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 59 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• DNA Index

• S-Phase%

• CD45 expression

• P16 metabolic way

Locations
Country Name City State
France CRLCC Centre Paul Papin Angers

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Angers French Innovative Leukemia Organisation

Country where clinical trial is conducted

France, 

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