LeukemiaNCT01138306
Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
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 biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Leukemia
- What is being tested?
- gene expression analysis, mutation analysis and flow cytometry
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosis of acute myeloid leukemia
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Implications of s-SHIP Expression and SHIP Alterations in AML
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia.
- Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays.
OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.
- Conditions
- Leukemia
- Being tested
- gene expression analysis, mutation analysis, flow cytometry, laboratory biomarker analysis
- Keywords
- childhood acute myeloid leukemia/other myeloid malignancies
- 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
mutation analysisGenetic
flow cytometryOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Secondary outcomes (2)
Overall survival
Relapse rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startFeb 2013
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Phoenix Ho, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138306
- Sponsor's protocol ID
- AAML10B5
- Other IDs
- COG-AAML10B5, CDR0000671462, NCI-2011-02223
- Status last verified
- May 2016
- First submitted
- 4 Jun 2010
- 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
- Implications of s-SHIP Expression and SHIP Alterations in AML
- ClinicalTrials.gov ID
- NCT01138306
- Acronym / sponsor ID
- AAML10B5
- Conditions
- Leukemia
- Keywords
- childhood acute myeloid leukemia/other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Jun 2010 (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 biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia.
- Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays.
OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Diagnosis of acute myeloid 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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Event-free survival
2 secondary outcomes
Overall survival
Relapse rate
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.
Phoenix Ho, MD principal investigator
Fred Hutchinson Cancer Center
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?
Event-free survival. 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.