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

NCT ID: NCT00188084

Last Updated: 2005-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Adult Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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DNA Index

Intervention Type PROCEDURE

S-Phase%

Intervention Type PROCEDURE

CD45 expression

Intervention Type PROCEDURE

P16 metabolic way

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

15 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Laurence M Baranger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CRLCC Centre Paul Papin

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Agnès F CHASSEVENT, PhD

Role: CONTACT

Phone: 33-(0)2-41-35-27-00

Email: [email protected]

Facility Contacts

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Agnès F CHASSEVENT, PhD

Role: primary

Other Identifiers

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GOELAMS 271-003

Identifier Type: -

Identifier Source: secondary_id

PHRC03-02

Identifier Type: -

Identifier Source: org_study_id