Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia

• Conditions: Lymphoma; Leukemia

• Registration Number: NCT01185886
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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).

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Study Start: 2011-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (21)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Hopital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

U.Z. Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Centre Hospitalier Regional De La Citadelle; 🇧🇪 Liege, Belgium

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

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