LeukemiaNCT01434329
S8600-S9031-S9333-A, Study of DNA in Samples From Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Studying samples of blood and 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. It may also help doctors predict how patients respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- DNA methylation analysis, gene expression analysis and microarray analysis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled on S8600, S9031 or S9333 who consented to use of specimens for future research
DISEASE CHARACTERISTICS:
- De novo acute myeloid leukemia (AML) patients with normal cytogenetics treated with curative therapy who survived at least 28 days after therapy started
- Samples will be taken from the following studies: SWOG-8600, SWOG-9031, SWOG-9333, SWOG-9500, SWOG-S9918, SWOG-S0106, and SWOG-S0112
- Blood or marrow specimens can be used
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: S8600-S9031-S9333-A, Identification of Differentially Methylated Genomic Regions That Are Prognostically Significant in AML
RATIONALE: Studying samples of blood and 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. It may also help doctors predict how patients respond to treatment.
PURPOSE: This research trial studies DNA in samples from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- To identify differentially methylated regions (DMRs) associated with overall survival (OS) of acute myeloid leukemia (AML) patients with normal cytogenetics.
- To develop and evaluate in an independent validation set a prognostic score for OS based on the identified DMR.
- To determine whether the prognostic score can group patients into risk groups based on OS.
OUTLINE: Archived blood or bone marrow samples are analyzed for DNA methylation alterations by CHARM array-based genome assay. Each patient's clinical data is also collected.
- Conditions
- Leukemia
- Being tested
- DNA methylation analysis, gene expression analysis, microarray analysis, laboratory biomarker analysis, medical chart review
- Keywords
- untreated adult 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.
DNA methylation analysisGenetic
gene expression analysisGenetic
microarray analysisGenetic
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of DMRs associated with OS
Measured: immediate
Development and evaluation of a prognostic score of OS based on DMRs identified
Measured: immediate
Prognostic score able to group AML patients into risk groups
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionDec 2015
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 SWOG Cancer Research NetworkThe 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Min Fang, MD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434329
- Sponsor's protocol ID
- S8600-S9031-S9333-A
- Other IDs
- S8600-S9031-S9333-A, U10CA032102
- Status last verified
- Apr 2016
- First submitted
- 13 Sep 2011
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S8600-S9031-S9333-A, Identification of Differentially Methylated Genomic Regions That Are Prognostically Significant in AML
- ClinicalTrials.gov ID
- NCT01434329
- Acronym / sponsor ID
- S8600-S9031-S9333-A
- Conditions
- Leukemia
- Keywords
- untreated adult acute myeloid leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Sep 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 blood and 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. It may also help doctors predict how patients respond to treatment.
PURPOSE: This research trial studies DNA in samples from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- To identify differentially methylated regions (DMRs) associated with overall survival (OS) of acute myeloid leukemia (AML) patients with normal cytogenetics.
- To develop and evaluate in an independent validation set a prognostic score for OS based on the identified DMR.
- To determine whether the prognostic score can group patients into risk groups based on OS.
OUTLINE: Archived blood or bone marrow samples are analyzed for DNA methylation alterations by CHARM array-based genome assay. Each patient's clinical data is also collected.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled on S8600, S9031 or S9333 who consented to use of specimens for future research
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 methylation analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| microarray analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
Identification of DMRs associated with OS
Time frame: immediate
Development and evaluation of a prognostic score of OS based on DMRs identified
Time frame: immediate
Prognostic score able to group AML patients into risk groups
Time frame: immediate
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 15 Apr 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.
Min Fang, 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 SWOG Cancer Research Network.
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 15 Apr 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?
Identification of DMRs associated with OS (time frame: immediate). 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 15 Apr 2016.