Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia
Childhood Cancer Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk ALL Pilot Project: Application of Array-Based Methods and Gene Re-Sequencing to Identify Candidate Molecular Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia
RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk acute lymphoblastic leukemia.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
OBJECTIVES:
- Identify regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts from pediatric patients with high-risk acute lymphoblastic leukemia (ALL) using Affymetrix GeneChip Mapping 500K array sets. (Pilot project)
- Identify regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)
- Define gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays.
- Assess the global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips.
- Utilize array-generated gene expression data and data for CNAs and uniparental disomy to prioritize candidate genes and genomic regions for resequencing.
- Characterize epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)
- Discover candidate therapeutic targets for these patients by identifying genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing. (Pilot project)
- Discover candidate therapeutic targets for these patients by next generation sequencing technologies, including whole genome, whole transcriptome, and whole exome. (Expansion project)
OUTLINE: This is a multicenter study.
Banked biological samples (bone marrow and peripheral blood) are analyzed using gene expression profiling, single-nucleotide polymorphism and genotyping assays, DNA copy number and loss of heterozygosity estimates, epigenetic profiling, and gene resequencing.
PROJECTED ACCRUAL: A total of 150 patient samples will be accrued for this study.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
DISEASE CHARACTERISTICS:
Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL)
- High-risk disease
Participation in clinical trial COG-P9906 required (pilot project)
- In complete remission
- Consented to future studies using banked tissue specimens
Participation in clinical trial and COG-AALL03B1 and linked therapeutic studies COG-AALL0232 and COG- AALL0331(expansion project)
- Experienced a bone marrow relapse within 36 months of initial diagnosis
- Consented to future studies using banked tissue specimens
- Have matched ALL blast and germline specimens
- Demographic, clinical and pathologic data elements for these biospecimens available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets
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Identification of regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)
|
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Gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays
|
|
Global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips
|
|
Epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)
|
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Prioritization of candidate genes and genomic regions for resequencing using array-generated gene expression data and data for CNAs
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Identification of genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Stephen P. Hunger, MD, Children's Hospital Colorado Center for Cancer and Blood Disorders
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AALL06B1
- COG-AALL06B1 (Andere Kennung: Children's Oncology Group)
- CDR0000496763 (Andere Kennung: Clinical Trials.gov)
- NCI-2009-00314 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
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