S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 29, 2010 | ||||
| Last Updated Date | December 13, 2012 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT01059734 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia | ||||
| Official Title ICMJE | Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML) | ||||
| Brief 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. |
||||
| Detailed Description | OBJECTIVES:
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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients enrolled on S0931, S9126, S9333 or S9500 consenting to use of specimens for future research |
||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 357 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01059734 | ||||
| Other Study ID Numbers ICMJE | CDR0000664320, S9031-S9126-S9333-S9500-B, U10CA032102 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Southwest Oncology Group | ||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Southwest Oncology Group | ||||
| Verification Date | December 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||