Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01284010
First received: January 25, 2011
Last updated: July 1, 2016
Last verified: July 2016
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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 |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Further study details as provided by Alliance for Clinical Trials in Oncology:
Primary Outcome Measures:
- complete remission rate [ Time Frame: Up to 7 Years ] [ Designated as safety issue: No ]
- disease free survival [ Time Frame: Up to 7 Years ] [ Designated as safety issue: No ]
- cumulative incidence of relapse [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
- event-free survival [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
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.
|
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 |
Detailed Description:
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 (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Acute lymphoblastic leukemia (ALL) patients treated on protocols CALGB 9511, 19802, 10001, 10102, and 10403, and who have been registered on the companion study CALGB 9665 (The CALGB Leukemia Tissue Bank)
Criteria
Inclusion:
• Diagnostic and germ-line specimens from patients with acute lymphoblastic leukemia (ALL) treated on protocols CALGB 9511, CALGB-19802, CALGB-10001, CALGB-10102, and CALGB-10403 and who have been registered on the companion study CALGB-9665 (The CALGB Leukemia Tissue Bank)
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
Locations
| United States, Illinois | |
| Cancer and Leukemia Group B | |
| Chicago, Illinois, United States, 60606 | |
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
| Study Chair: | James Downing, MD | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | Alliance for Clinical Trials in Oncology |
| ClinicalTrials.gov Identifier: | NCT01284010 History of Changes |
| Other Study ID Numbers: | CALGB-21001 RC1CA145707 P30CA014236 CDR0000694150 |
| Study First Received: | January 25, 2011 |
| Last Updated: | July 1, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alliance for Clinical Trials in Oncology:
|
adult acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016