LeukemiaNCT01232842
Biomarker Study in Tissue Samples From 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 identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Leukemia
- What is being tested?
- cytogenetic analysis, HUMARA assay and fluorescence activated cell sorting
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jul 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 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diagnosed with acute myeloid leukemia.
DISEASE CHARACTERISTICS:
- Diagnosed with acute myeloid leukemia
- Known CD34+ progenitor cells
- Available freshly isolated, uncultured cell samples
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors.
OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.
- Conditions
- Leukemia
- Being tested
- cytogenetic analysis, HUMARA assay, fluorescence activated cell sorting, laboratory biomarker analysis
- Keywords
- adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytogenetic analysisGenetic
HUMARA assayOther
fluorescence activated cell sortingOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors
Extent of clonal hematopoiesis in small numbers of AML cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJul 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
- Roland Walter, MD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232842
- Sponsor's protocol ID
- AAML11B4
- Other IDs
- COG-AAML11B4, NCI-2011-02843, AAML11B4
- Status last verified
- Jul 2016
- First submitted
- 30 Oct 2010
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns
- ClinicalTrials.gov ID
- NCT01232842
- Acronym / sponsor ID
- AAML11B4
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia, 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
- Oct 2010
- Primary completion
- Jul 2016 (actual)
- First posted
- 2 Nov 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 identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors.
OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosed with 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 |
|---|---|---|
| cytogenetic analysis | Genetic | – |
| HUMARA assay | Other | – |
| fluorescence activated cell sorting | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors
Extent of clonal hematopoiesis in small numbers of AML cells
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 11 Jul 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.
Roland Walter, MD, PhD 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 11 Jul 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?
Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors. 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 11 Jul 2016.