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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:
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. |
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| 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 |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 400 | ||||
| Start Date † | November 2003 | ||||
| Completion Date | September 2005 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 59 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| 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 † |
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| Information Provided By | University Hospital, Angers | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | October 27, 2005 | ||||