Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01642069
First received: July 15, 2012
Last updated: July 27, 2012
Last verified: July 2012
| Tracking Information | |||||
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| First Received Date ICMJE | July 15, 2012 | ||||
| Last Updated Date | July 27, 2012 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
NUP98/JARID1A as a recurrent aberration in pediatric AMKL [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01642069 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 | Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia | ||||
| Official Title ICMJE | NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia | ||||
| Brief Summary | RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking into genes in samples from younger patients with acute megakaryoblastic leukemia (AMKL). |
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| Detailed Description | OBJECTIVES:
OUTLINE: Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or mixed-lineage leukemia (MLL)-rearrangements, and other gene expression profiling by reverse-transcriptase polymerase chain reaction (RT-PCR) and karyotyping or fluorescence in situ hybridization ( FISH). Results are then compared with each patient's outcome data. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Leukemia | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | up to 30 Years | ||||
| 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 | NCT01642069 | ||||
| Other Study ID Numbers ICMJE | CDR0000736633, COG-AAML12B9 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Peter C. Adamson, Children's Oncology Group - Group Chair Office | ||||
| Study Sponsor ICMJE | Children's Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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