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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
-
-
South Carolina
-
Charleston, South Carolina, Spojené státy, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
|---|
|
Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets
|
|
Identification of regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)
|
|
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)
|
|
Prioritization of candidate genes and genomic regions for resequencing using array-generated gene expression data and data for CNAs
|
|
Identification of genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Stephen P. Hunger, MD, Children's Hospital Colorado Center for Cancer and Blood Disorders
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AALL06B1
- COG-AALL06B1 (Jiný identifikátor: Children's Oncology Group)
- CDR0000496763 (Jiný identifikátor: Clinical Trials.gov)
- NCI-2009-00314 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .