Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT01185886|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2010
Last Update Posted : July 28, 2017
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.
|Condition or disease||Intervention/treatment|
|Leukemia Lymphoma||Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Other: pharmacogenomic studies|
- 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).
|Study Type :||Observational|
|Actual Enrollment :||1200 participants|
|Official Title:||Translational Research - Observational Study for Identification of New Possible Prognostic Factors and Future Therapeutic Targets in Children With Acute Lymphoblastic Leukemia (ALL)|
|Actual Study Start Date :||June 2011|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
- Event-free survival
- Disease-free interval from complete remission
- Response to pre-phase standard therapy
- Adverse events to induction standard therapy
- Overall survival
- Biomarker levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185886
|Principal Investigator:||Helene Cave||CHU - Hopital Robert Debre|
|Principal Investigator:||Yves Benoit, MD||Universitair Ziekenhuis Gent|
|Principal Investigator:||Yves Bertrand, MD||Hospices Civils de Lyon|