LeukemiaNCT01553162
Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that 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?
- DNA analysis, RNA analysis and gene expression analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to 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: Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
DISEASE CHARACTERISTICS:
- Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
- Samples from patients treated and not treated with Dex and Pred
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients
RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.
- Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients > 10 years old in response to both Dex and Pred.
OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.
- Conditions
- Leukemia
- Being tested
- DNA analysis, RNA analysis, gene expression analysis, laboratory biomarker analysis
- Keywords
- B-cell childhood acute lymphoblastic leukemia, untreated 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.
DNA analysisGenetic
RNA analysisGenetic
gene expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old
Genes that are required for efficient apoptosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startApr 2012
- Primary 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Miles A. Pufall, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553162
- Sponsor's protocol ID
- AALL12B4
- Other IDs
- COG-AALL12B4, CDR0000728515, AALL12B4, NCI-2012-00704
- Status last verified
- May 2016
- First submitted
- 10 Mar 2012
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients
- ClinicalTrials.gov ID
- NCT01553162
- Acronym / sponsor ID
- AALL12B4
- Conditions
- Leukemia
- Keywords
- B-cell childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2012
- Primary completion
- May 2016 (actual)
- First posted
- 14 Mar 2012 (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: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.
- Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients > 10 years old in response to both Dex and Pred.
OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.
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
- Patients diagnosed with high-risk B-cell precursor 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 |
|---|---|---|
| DNA analysis | Genetic | – |
| RNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old
Genes that are required for efficient apoptosis
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 18 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.
Miles A. Pufall, PhD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Children's Oncology Group.
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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old. The study lists 2 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 18 May 2016.