Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01035307
First received: December 17, 2009
Last updated: April 23, 2010
Last verified: April 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Studying samples of tissue 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 biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.
| Condition | Intervention |
|---|---|
|
Leukemia |
Genetic: gene expression analysis Genetic: microarray analysis Genetic: proteomic profiling Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Genomic and Proteomic Profiling of Childhood AML |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples [ Designated as safety issue: No ]
- Classification of AML-based signal transduction mechanisms [ Designated as safety issue: No ]
- Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and gene expression profiles. [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
- To classify AML-based signal transduction mechanisms.
- To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.
OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:
- Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
- Relapsed disease (early or late)
- In continuous complete remission
- Previously enrolled on POG-9421
- Tissue samples available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Norman J. Lacayo, Stanford Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01035307 History of Changes |
| Other Study ID Numbers: | CDR0000659560, COG-AAML09B2 |
| Study First Received: | December 17, 2009 |
| Last Updated: | April 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013