LeukemiaNCT00898092
Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
Trial summary
RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 15 to 59 years
- Conditions the study is for
- Leukemia
- What is being tested?
- microarray analysis, molecular genetic technique and mutation analysis
- How many people
- 735 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 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 15 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients enrolled on CALGB 19808 with tissue previously submitted to the CALGB Leukemia Tissue Bank
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
- Normal karyotype
- Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required
- No additional samples required
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
About this study
Official title: Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project
RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.
- Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.
- Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.
OUTLINE: This is a multicenter, pilot study.
Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- microarray analysis, molecular genetic technique, mutation analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction
- Keywords
- adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute eosinophilic leukemia, adult acute basophilic leukemia, untreated adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Basophilic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
molecular genetic techniqueGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
reverse transcriptase-polymerase chain reactionGenetic
diagnostic laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA. Receives: Genetic: microarray analysis; Genetic: molecular genetic technique; Genetic: mutation analysis; Genetic: polymerase chain reaction; Genetic: reverse transcriptase-polymerase chain reaction; Other: diagnostic laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures
Measured: Baseline
Differential microRNA expression
Measured: Baseline
Relative contribution of genetic markers in predicting clinical outcome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2012
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 Alliance for Clinical Trials in OncologyThe 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
- 735 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Guido Marcucci, MD, Study chair, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898092
- Sponsor's protocol ID
- CALGB-20502
- Other IDs
- CALGB-20502, U10CA031946, U10CA180821, CDR0000491133
- Status last verified
- Aug 2021
- First submitted
- 9 May 2009
- Last updated
- 17 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project
- ClinicalTrials.gov ID
- NCT00898092
- Acronym / sponsor ID
- CALGB-20502
- Conditions
- Leukemia
- Keywords
- adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 735 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006 (actual)
- Primary completion
- Dec 2012 (actual)
- First posted
- 12 May 2009 (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: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.
- Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.
- Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.
OUTLINE: This is a multicenter, pilot study.
Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: microarray analysis, Genetic: molecular genetic technique, Genetic: mutation analysis, Genetic: polymerase chain reaction, Genetic: reverse transcriptase-polymerase chain reaction, Other: diagnostic laboratory biomarker analysisPeripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA. |
Who may qualify
- Ages
- 15 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients enrolled on CALGB 19808 with tissue previously submitted to the CALGB Leukemia Tissue Bank
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 |
|---|---|---|
| microarray analysis | Genetic | Group 1 |
| molecular genetic technique | Genetic | Group 1 |
| mutation analysis | Genetic | Group 1 |
| polymerase chain reaction | Genetic | Group 1 |
| reverse transcriptase-polymerase chain reaction | Genetic | Group 1 |
| diagnostic laboratory biomarker analysis | Other | Group 1 |
Primary outcome
Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures
Time frame: Baseline
Differential microRNA expression
Time frame: Baseline
Relative contribution of genetic markers in predicting clinical outcome
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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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.
Guido Marcucci, MD study chair
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures (time frame: Baseline). 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 17 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.