LeukemiaNCT01298414
Biomarkers in Bone Marrow 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 bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Leukemia
- What is being tested?
- RNA analysis and laboratory biomarker analysis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Diagnosis of acute myeloid leukemia
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
- Fresh human bone marrow samples obtained from orthopedic surgery at the Tissue Donation Program of The Feinstein Institute and the Children Oncology Group (COG) Myeloid Disease Biorepository
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- To study the effect of niche mesenchymal stromal cells (MSC) exposure on microRNAs (miR) expression in pediatric AML at different time points and compare those profiles to the miR profiles at baseline.
- To focus on four pediatric AML-specific miRs (miR34a, miR538e, miR193e, and miR198) which show the most significant differential expression after in vivo niche exposure at four months (hematogenous spread).
- To determine whether altered miR expression reflects or causes the metastatic invasion pattern of AML.
OUTLINE: Bone marrow-derived mesenchymal stromal cell (MSC) samples are implanted subcutaneously in NOD/SCID mice. Cells are then harvested at day 0, 1 month, and 4 months post-implantation. miRNA is isolated and analyzed by Ilumina MicroRNA Expression Profiling single Beadchip. The obtained data is then analyzed by the Illumina Genome Studio Analysis Software.
- Conditions
- Leukemia
- Being tested
- RNA analysis, 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.
RNA analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment
Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles
Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2011
- 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
- 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
- Sarah R.I. Vaiselbuh, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298414
- Sponsor's protocol ID
- AAML11B9
- Other IDs
- COG-AAML11B9, NCI-2011-02849, AAML11B9
- Status last verified
- May 2016
- First submitted
- 16 Feb 2011
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche
- ClinicalTrials.gov ID
- NCT01298414
- Acronym / sponsor ID
- AAML11B9
- Conditions
- Leukemia
- Keywords
- childhood acute myeloid leukemia/other myeloid malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Feb 2011 (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 bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- To study the effect of niche mesenchymal stromal cells (MSC) exposure on microRNAs (miR) expression in pediatric AML at different time points and compare those profiles to the miR profiles at baseline.
- To focus on four pediatric AML-specific miRs (miR34a, miR538e, miR193e, and miR198) which show the most significant differential expression after in vivo niche exposure at four months (hematogenous spread).
- To determine whether altered miR expression reflects or causes the metastatic invasion pattern of AML.
OUTLINE: Bone marrow-derived mesenchymal stromal cell (MSC) samples are implanted subcutaneously in NOD/SCID mice. Cells are then harvested at day 0, 1 month, and 4 months post-implantation. miRNA is isolated and analyzed by Ilumina MicroRNA Expression Profiling single Beadchip. The obtained data is then analyzed by the Illumina Genome Studio Analysis Software.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 30 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 |
|---|---|---|
| RNA analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment
Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles
Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive)
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 19 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.
Sarah R.I. Vaiselbuh, MD principal investigator
Feinstein Institute for Medical Research
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 19 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?
miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment. 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 19 May 2016.