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

Sponsor:

Collaborator:

National Cancer Institute (NCI)

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

Tracking Information

First Received Date ^ICMJE

January 25, 2011

Last Updated Date

January 25, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

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

Biomarkers in Blood and Bone Marrow Samples From Patients With Acute Lymphoblastic Leukemia

Official Title ^ICMJE

Genome-Wide Analysis of Genetic Alterations in Adult Acute Lymphoblastic Leukemia

Brief Summary

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.

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.

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

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 Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Not Provided

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01284010

Other Study ID Numbers ^ICMJE

CDR0000694150, CALGB-21001

Has Data Monitoring Committee

Not Provided

Responsible Party

Monica M. Bertagnolli, Cancer and Leukemia Group B

Study Sponsor ^ICMJE

Cancer and Leukemia Group B

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

James Downing, MD

St. Jude Children's Research Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top