LeukemiaNCT00897182
Identifying Cancer Genes in in Blood and Bone Marrow Samples From Patients With Acute Myeloid Leukemia
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 2 sites in United States.
Trial summary
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- microarray analysis and polymerase chain reaction
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with acute myeloid leukemia.
- Enrolled on CALGB acute myeloid leukemia (AML) treatment studies AND concurrently enrolled on Leukemia Tissue Bank Protocol CALGB-9665
- Short-term or long-term survivor
- Bone marrow and/or peripheral blood obtained at diagnosis
- Leukemia is one of the following cytogenetic subtypes:
- t(8;21)
- t(15;17)
- inv(16)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
About this study
Official title: Identification of Target Genes for Diagnosis and Prognosis of AML Using a Custom-Design Microarray
RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment.
PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
- To identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia.
- To correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations.
OUTLINE: Blood and/or bone marrow samples previously procured from patients on CALGB-9665 are obtained from the CALGB Leukemia Tissue Bank from patients enrolled on CALGB AML treatment studies. Mononuclear cells are isolated from samples and mRNA is extracted. Gene expression profiles are analyzed via custom mRNA microarray and confirmed by quantitative real-time PCR.
- Conditions
- Leukemia
- Being tested
- microarray analysis, polymerase chain reaction
- Keywords
- adult acute myeloid leukemia in remission, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(8;21)(q22;q22), childhood acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, untreated adult acute myeloid leukemia, untreated childhood acute myeloid leukemia and 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.
microarray analysisGenetic
polymerase chain reactionGenetic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This is a CALGB Leukemia Tissue Bank project makes use of tissue from patients who have previously provided their consent. Diagnostic samples from patients enrolled on CALGB AML treatment studies (eg, CALGB 9621, 9710, and 19808) and who have been registered on the companion Leukemia Tissue Bank Protocol CALGB 9665 were used. Receives: Genetic: microarray analysis; Genetic: polymerase chain reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of increased or decreased expression of same transcripts with disease outcome
Measured: baseline
Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia
Measured: baseline
Identification of individual genes that are differentially expressed between the subtypes of AMLs
Measured: baseline
Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations
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 2008
- Primary completionMar 2014
- Study completionMar 2014
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
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
- Janet Rowley, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897182
- Sponsor's protocol ID
- CALGB-20801
- Other IDs
- CALGB-20801, CDR0000595708, NCI-2009-00462
- Status last verified
- Jul 2016
- First submitted
- 9 May 2009
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Target Genes for Diagnosis and Prognosis of AML Using a Custom-Design Microarray
- ClinicalTrials.gov ID
- NCT00897182
- Acronym / sponsor ID
- CALGB-20801
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia in remission, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(8;21)(q22;q22), childhood acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (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: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment.
PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
- To identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia.
- To correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations.
OUTLINE: Blood and/or bone marrow samples previously procured from patients on CALGB-9665 are obtained from the CALGB Leukemia Tissue Bank from patients enrolled on CALGB AML treatment studies. Mononuclear cells are isolated from samples and mRNA is extracted. Gene expression profiles are analyzed via custom mRNA microarray and confirmed by quantitative real-time PCR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: microarray analysis, Genetic: polymerase chain reactionThis is a CALGB Leukemia Tissue Bank project makes use of tissue from patients who have previously provided their consent. Diagnostic samples from patients enrolled on CALGB AML treatment studies (eg, CALGB 9621, 9710, and 19808) and who have been registered on the companion Leukemia Tissue Bank Protocol CALGB 9665 were used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients 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 |
|---|---|---|
| microarray analysis | Genetic | Group 1 |
| polymerase chain reaction | Genetic | Group 1 |
Primary outcome
Correlation of increased or decreased expression of same transcripts with disease outcome
Time frame: baseline
Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia
Time frame: baseline
Identification of individual genes that are differentially expressed between the subtypes of AMLs
Time frame: baseline
Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations
Time frame: baseline
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 4 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.
Janet Rowley, MD study chair
University of Chicago
2 sites 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 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Correlation of increased or decreased expression of same transcripts with disease outcome (time frame: baseline). 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?
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 4 Jul 2016.