LeukemiaNCT00896766
Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia
An observational study of Leukemia, run by Children's Oncology Group at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Leukemia
- What is being tested?
- loss of heterozygosity analysis, microarray analysis and polymorphism analysis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Leukemia
- Being tested
- loss of heterozygosity analysis, microarray analysis, polymorphism analysis, tumor replication error analysis
- Keywords
- childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loss of heterozygosity analysisGenetic
microarray analysisGenetic
polymorphism analysisGenetic
tumor replication error analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2006
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen P. Hunger, MD, Study chair, Children's Hospital Colorado Center for Cancer and Blood Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896766
- Sponsor's protocol ID
- AALL06B1
- Other IDs
- COG-AALL06B1, CDR0000496763, NCI-2009-00314
- Status last verified
- May 2016
- First submitted
- 9 May 2009
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00896766
- Acronym / sponsor ID
- AALL06B1
- Conditions
- Leukemia
- Keywords
- childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loss of heterozygosity analysis | Genetic | – |
| microarray analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| tumor replication error analysis | Genetic | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P. Hunger, MD study chair
Children's Hospital Colorado Center for Cancer and Blood Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.