LeukemiaNCT01059734
S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Studying samples of 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. PURPOSE: This research study is looking at biomarker expression in bone marrow samples from patients with acute myeloid leukemia. 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 analysis, RNA analysis and mutation analysis
- How many people
- 357 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2012
- 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 S0931, S9126, S9333 or S9500 consenting to use of specimens for future research
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
- All subtypes allowed (except acute promyelocytic leukemia [M3])
- Previously untreated OR relapsed/refractory disease
- Isolated RNA specimens from bone marrow aspirate samples available from patients who participated on SWOG-9031, SWOG-9333 (cytarabine/daunorubicin hydrochloride induction arm only), SWOG-9500, or SWOG-9126
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)
RATIONALE: Studying samples of 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.
PURPOSE: This research study is looking at biomarker expression in bone marrow samples from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- Estimate the distributions of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms (SNPs) in patients with newly diagnosed acute myeloid leukemia (AML).
- Estimate the distributions of mutations in TOP2 phosphorylation sites (by SNP analysis) in these patients.
- Investigate whether expression of TOP2 or mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in these patients.
- Test whether TOP2 expression correlates with complete remission rates, relapse-free survival, and overall survival of these patients.
- Conduct preliminary analyses to estimate the distributions of TOP2 expression and mutations in TOP2 phosphorylation sites (by SNP analysis) in patients with relapsed and/or refractory AML.
- Investigate whether expression of TOP2 and mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in patients with relapsed and/or refractory AML.
- Test whether TOP2 expression and mutations in TOP2 phosphorylation sites differ between previously untreated and relapsed/refractory AML patients.
OUTLINE: This is a multicenter study.
Archived RNA specimens are analyzed for topoisomerase 2 transcriptional expression by quantitative real-time polymerase chain reaction (PCR) and for mutations within TOP2 phosphorylation sites by single nucleotide polymorphism analysis.
- Conditions
- Leukemia
- Being tested
- DNA analysis, RNA analysis, mutation analysis, polymerase chain reaction, polymorphism analysis
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), secondary acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute megakaryoblastic leukemia (M7)
- Medical subject headings
- Leukemia, Congenital Abnormalities, Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Megakaryoblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
RNA analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms
Measured: immediate
Distributions of mutations in TOP2 phosphorylation sites
Measured: immediate
Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival
Measured: immediate
Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anjali Advani, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059734
- Sponsor's protocol ID
- S9031-S9126-S9333-S9500-B
- Other IDs
- S9031-S9126-S9333-S9500-B, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 29 Jan 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
PubMed 25527568Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
PubMed 24383844
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01059734
- Acronym / sponsor ID
- S9031-S9126-S9333-S9500-B
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, adult erythroleukemia (M6a)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Feb 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 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.
PURPOSE: This research study is looking at biomarker expression in bone marrow samples from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- Estimate the distributions of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms (SNPs) in patients with newly diagnosed acute myeloid leukemia (AML).
- Estimate the distributions of mutations in TOP2 phosphorylation sites (by SNP analysis) in these patients.
- Investigate whether expression of TOP2 or mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in these patients.
- Test whether TOP2 expression correlates with complete remission rates, relapse-free survival, and overall survival of these patients.
- Conduct preliminary analyses to estimate the distributions of TOP2 expression and mutations in TOP2 phosphorylation sites (by SNP analysis) in patients with relapsed and/or refractory AML.
- Investigate whether expression of TOP2 and mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in patients with relapsed and/or refractory AML.
- Test whether TOP2 expression and mutations in TOP2 phosphorylation sites differ between previously untreated and relapsed/refractory AML patients.
OUTLINE: This is a multicenter study.
Archived RNA specimens are analyzed for topoisomerase 2 transcriptional expression by quantitative real-time polymerase chain reaction (PCR) and for mutations within TOP2 phosphorylation sites by single nucleotide polymorphism analysis.
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 S0931, S9126, S9333 or S9500 consenting 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 analysis | Genetic | – |
| RNA analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms
Time frame: immediate
Distributions of mutations in TOP2 phosphorylation sites
Time frame: immediate
Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival
Time frame: immediate
Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics
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 6 Mar 2015.
- Derived from this study: PubMed 25527568Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
- Derived from this study: PubMed 24383844Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
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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.
Anjali Advani, MD principal investigator
The Cleveland Clinic
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 6 Mar 2015. 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?
Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms (time frame: immediate). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059734, which also lists 2 linked publications.
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 6 Mar 2015.