Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01284010 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 26, 2011
Last Update Posted
: August 8, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment |
---|---|
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 |
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.
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | January 2100 |
Group/Cohort | Intervention/treatment |
---|---|
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 |
- complete remission rate [ Time Frame: Up to 7 Years ]
- disease free survival [ Time Frame: Up to 7 Years ]
- cumulative incidence of relapse [ Time Frame: Up to 7 years ]
- overall survival [ Time Frame: Up to 7 years ]
- event-free survival [ Time Frame: Up to 7 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284010
United States, Illinois | |
Cancer and Leukemia Group B | |
Chicago, Illinois, United States, 60606 |
Study Chair: | James Downing, MD | St. Jude Children's Research Hospital |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT01284010 History of Changes |
Other Study ID Numbers: |
CALGB-21001 RC1CA145707 ( U.S. NIH Grant/Contract ) P30CA014236 ( U.S. NIH Grant/Contract ) CDR0000694150 ( Registry Identifier: NCI Physician Data Query ) |
First Posted: | January 26, 2011 Key Record Dates |
Last Update Posted: | August 8, 2017 |
Last Verified: | August 2017 |
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 |