Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia
- Conditions
- LymphomaLeukemia
- Registration Number
- NCT01185886
- Brief Summary
RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help the study of cancer in the future. Studying these samples in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is collecting and looking at blood and tissue samples in children with newly diagnosed acute lymphoblastic leukemia.
- Detailed Description
OBJECTIVES:
* Collect clinical data in parallel with biological data and samples from children with newly diagnosed acute lymphoblastic leukemia for biobanking, and use part of the biobanked material to perform specific translational projects to achieve objectives II-IV.
* To identify new prognostic factors (e.g., minimal-residual disease \[MRD\] significance in small subgroups, miRNAs expression profile, PAX5 mutation, genetic abnormalities in T-cell acute lymphoblastic leukemia \[T-ALL\], and RAS pathway activation) and future therapeutic targets in children with newly diagnosed acute lymphoblastic leukemia.
* To identify leukemia cell genetic alterations (e.g., mutations in T-ALL and miRNA expression in B-cell acute lymphoblastic leukemia \[B-ALL\]) and related molecular pathways (e.g., RAS pathway) underlying leukemogenesis.
* To identify patient pharmacogenetic polymorphisms impacting individual response to corticosteroids as part of standard therapy and investigate their prognostic significance.
OUTLINE: This is a prospective observational biobanking study.
Patients undergo clinical evaluation, laboratory tests, and imaging periodically. Data are collected before, during, and after first-line standard therapy. Clinical data are collected from all patients in parallel with the biological data and samples. Biological samples are partly used to perform specific translational research (TR) projects. Remaining biological materials are stored for future research.
The following TR projects are performed on the biological samples for this study. Biological samples are analyzed for allele-specific amplification of Ig/TCR clonal rearrangements to quantify minimal-residual disease (MRD) via real-time PCR (TR1 Project); miRNA expression via qPCR (TR 2 Project); the detection of main point mutations via high-resolution melting PCR (TR 3 Project); genetic polymorphisms via real-time TaqMan allelic-discrimination method (TR 4 Project); clinical significance of genetic abnormalities via quantitative real-time RT-PCR, direct sequencing, and fluorescence in situ hybridization (TR 5 Project); and RAS pathway activation via single-nucleotide polymorphism (SNP) analysis and gene-expression analysis (TR 6 Project).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival Overall survival Disease-free interval from complete remission Response to pre-phase standard therapy Adverse events to induction standard therapy Biomarker levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Instituto Portugues De Oncologia - Centro Do Porto
🇵🇹Porto, Portugal
U.Z. Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
Hospices Civils de Lyon
🇫🇷Lyon, France
Universitair Ziekenhuis Antwerpen
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Hopital Universitaire Des Enfants Reine Fabiola
🇧🇪Brussels, Belgium
Centre Hospitalier Regional De La Citadelle
🇧🇪Liege, Belgium
CHRU de Lille
🇫🇷Lille, France
Hopital Jean Bernard
🇫🇷Poitiers, France
CHU de Toulouse - C.H.U. De Toulouse - Hopital Des Enfants
🇫🇷Toulouse, France
Hopital Arnaud De Villeneuve
🇫🇷Montpellier, France
CHRU de Besancon - Hopital Saint-Jacques
🇫🇷Besancon, France
CHU de Caen - Hopital Cote de Nacre
🇫🇷Caen, France
CHU de Grenoble - La Tronche - Hôpital A. Michallon
🇫🇷Grenoble, France
CHU - Hopital Robert Debre
🇫🇷Paris, France
CHU de Nice - Hopital De L'Archet
🇫🇷Nice, France
CHU de Reims - American Memorial Hospital
🇫🇷Reims, France
Centre Hospitalier Félix Guyon
🇫🇷Saint-Denis, France
Hopitaux Universitaires de Strasbourg - Hautepierre
🇫🇷Strasbourg, France