LeukemiaNCT01035307
Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421
An observational study of Leukemia, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tissue 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 Up to 20 years
- Conditions the study is for
- Leukemia
- What is being tested?
- gene expression analysis, microarray analysis and proteomic profiling
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Previously enrolled on POG 9421
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:
- Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
- Relapsed disease (early or late)
- In continuous complete remission
- Previously enrolled on POG-9421
- Tissue samples available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Genomic and Proteomic Profiling of Childhood AML
RATIONALE: Studying samples of tissue 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 study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.
Read the detailed description
OBJECTIVES:
- To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
- To classify AML-based signal transduction mechanisms.
- To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.
OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.
- Conditions
- Leukemia
- Being tested
- gene expression analysis, microarray analysis, proteomic profiling, laboratory biomarker analysis
- Keywords
- childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
microarray analysisGenetic
proteomic profilingGenetic
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Genomic and Proteomic Profiling | Not described Receives: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: proteomic profiling; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples
Classification of AML-based signal transduction mechanisms
Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and gene expression profiles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startOct 2009
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Norman J. Lacayo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035307
- Sponsor's protocol ID
- AAML09B2
- Other IDs
- COG-AAML09B2, CDR0000659560, NCI-2011-02201
- Status last verified
- May 2016
- First submitted
- 17 Dec 2009
- 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
- Genomic and Proteomic Profiling of Childhood AML
- ClinicalTrials.gov ID
- NCT01035307
- Acronym / sponsor ID
- AAML09B2
- Conditions
- Leukemia
- Keywords
- childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009
- Primary completion
- May 2016 (actual)
- First posted
- 18 Dec 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: Studying samples of tissue 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 study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.
Detailed description
OBJECTIVES:
- To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
- To classify AML-based signal transduction mechanisms.
- To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.
OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genomic and Proteomic Profiling | – | Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: proteomic profiling, Other: laboratory biomarker analysis |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Previously enrolled on POG 9421
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 |
|---|---|---|
| gene expression analysis | Genetic | Genomic and Proteomic Profiling |
| microarray analysis | Genetic | Genomic and Proteomic Profiling |
| proteomic profiling | Genetic | Genomic and Proteomic Profiling |
| laboratory biomarker analysis | Other | Genomic and Proteomic Profiling |
Primary outcome
Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples
Classification of AML-based signal transduction mechanisms
Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and gene expression profiles.
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.
Norman J. Lacayo, MD principal investigator
Stanford University
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?
Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples. The study lists 3 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.