Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia
NCT ID: NCT00896766
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
150 participants
OBSERVATIONAL
2006-05-31
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk acute lymphoblastic leukemia.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Studying Genes in Samples From Younger Patients With Relapsed Acute Lymphoblastic Leukemia
NCT01625143
DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
NCT00899652
Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia
NCT01057290
DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia
NCT00897507
Study of Blood and Tissue Samples in Children With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT01185886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
loss of heterozygosity analysis
microarray analysis
polymorphism analysis
tumor replication error analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
1 Year
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen P. Hunger, MD
Role: STUDY_CHAIR
Children's Hospital Colorado Center for Cancer and Blood Disorders
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COG-AALL06B1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000496763
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00314
Identifier Type: REGISTRY
Identifier Source: secondary_id
AALL06B1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.