Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Cancer and Leukemia Group B
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01284010
First received: January 25, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
RATIONALE: Studying samples of blood and 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 studying biomarkers in blood and bone marrow samples from patients with acute lymphoblastic leukemia.
| Condition | Intervention |
|---|---|
|
Leukemia |
Genetic: DNA analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Acute Monoblastic Leukemia
Acute Myeloblastic Leukemia Type 5
Lymphosarcoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Correlation between alteration and gene, exon, and m-RNA expression with complete remission rate, disease-free survival, cumulative incidence of relapse, overall survival, and event-free survival [ Designated as safety issue: No ]
- Associations between genome-wide DNA copy number alterations and outcome in adult ALL and comparison of these data with already generated pediatric ALL [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To perform high-resolution, genome-wide profiling of DNA copy number alterations and loss-of-heterozygosity in samples from adult patients with acute lymphoblastic leukemia (ALL) obtained at diagnosis.
- To perform candidate gene resequencing of diagnostic ALL samples.
- To examine correlation of genetic alterations with outcome.
- To examine the correlation between microarray multi-gene and multi-exon expression signatures with specific alterations and outcome.
- To understand genetic events that contribute to the formation, development, and relapse of adult ALL by integrating the copy number and sequence alterations with the multi-gene signatures, and by comparing these data with data already generated in pediatric ALL.
OUTLINE: Diagnostic, complete remission, and germ-line specimens are analyzed for DNA profiling and gene resequencing by the Affymetrix SNP6.0 microarray platform, PCR, and fluorescence in situ hybridization (FISH). Frequency of genetic alterations are performed by the Agilent 2100 Bioanalyzer. Results are then compared with the data already generated from pediatric patients.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- This is a multicenter study.
- Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284010
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284010
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
| Principal Investigator: | James Downing, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01284010 History of Changes |
| Other Study ID Numbers: | CDR0000694150, CALGB-21001 |
| Study First Received: | January 25, 2011 |
| Last Updated: | January 25, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Immunoproliferative Disorders |
Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on February 27, 2015