Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
Primary Purpose
Leukemia
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
DNA analysis
fluorescence in situ hybridization
gene expression analysis
microarray analysis
mutation analysis
polymorphism analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Sponsored by
About this trial
This is an observational trial for Leukemia focused on measuring B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS:
Samples from patients diagnosed with B-progenitor AYA ALL from:
- The Children's Oncology Group high risk ALL Study AALL0232 (age 16-21)
- The St. Jude Children's Research Hospital (SJCRH) Total XV studies (age 16-21)
AYA ALL (from patients 22-30 years of age and from patients age 31-39 years) existing in the ALL Tissue Repositories of the adult National Cancer Institute (NCI) Cooperative Oncology Groups
- The Cancer and Leukemia Group B (CALGB)
- The Eastern Cooperative Oncology Group (ECOG)
- The Southwest Oncology Group (SWOG)
- Cryopreserved viable leukemic cell suspensions, obtained from bone marrow or peripheral blood at pretreatment and initial diagnosis
- Matched normal (germline) samples from end induction-remission bone marrow or blood samples or from buccal swabs, if available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Sites / Locations
Outcomes
Primary Outcome Measures
Identification of somatically acquired genetic copy number and sequence alterations
Associations between genetic lesions (including mutations and copy number alterations) and known prognostic factors such as age group and white blood count at the time of diagnosis group using a Fisher exact test or Chi squared
Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion
Secondary Outcome Measures
Full Information
NCT ID
NCT01653613
First Posted
July 27, 2012
Last Updated
July 9, 2013
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01653613
Brief Title
Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
Official Title
Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia
Study Type
Observational
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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. It may also help doctors find better ways to treat cancer.
PURPOSE: This laboratory study is looking into genes in samples from younger patients with acute lymphoblastic leukemia (ALL).
Detailed Description
OBJECTIVES:
To identify somatically acquired genetic copy number and sequence alterations at the time of diagnosis in adolescent and young adults (AYA) acute lymphoblastic leukemia (ALL) samples and to correlate them with clinical and laboratory characteristics and outcome.
To identify specific microarray multi-gene and multi-exon expression signatures at the time of diagnosis and to correlate them with clinical and laboratory characteristics and outcome.
To gain insights into the genetic events that contribute to the formation, development and relapse of AYA ALL by integrating the copy number and sequence alterations with the multi-gene signatures and by comparing these with data already generated in pediatric ALL.
OUTLINE: Cryopreserved samples are analyzed for DNA copy number alterations and loss-of-heterozygosity, gene expression profiling, and mutation analysis by single nucleotide polymorphism (SNP) microarrays, Affymetrix Exon arrays, and whole genome amplification (WGA, Repli-G Qiagen). Confirmation studies are then done by fluorescence in situ hybridization (FISH), reverse transcriptase (RT)-polymerase chain reaction (PCR), and rapid amplification of cDNA ends (RACE).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
7. Study Design
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
fluorescence in situ hybridization
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Identification of somatically acquired genetic copy number and sequence alterations
Title
Associations between genetic lesions (including mutations and copy number alterations) and known prognostic factors such as age group and white blood count at the time of diagnosis group using a Fisher exact test or Chi squared
Title
Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Samples from patients diagnosed with B-progenitor AYA ALL from:
The Children's Oncology Group high risk ALL Study AALL0232 (age 16-21)
The St. Jude Children's Research Hospital (SJCRH) Total XV studies (age 16-21)
AYA ALL (from patients 22-30 years of age and from patients age 31-39 years) existing in the ALL Tissue Repositories of the adult National Cancer Institute (NCI) Cooperative Oncology Groups
The Cancer and Leukemia Group B (CALGB)
The Eastern Cooperative Oncology Group (ECOG)
The Southwest Oncology Group (SWOG)
Cryopreserved viable leukemic cell suspensions, obtained from bone marrow or peripheral blood at pretreatment and initial diagnosis
Matched normal (germline) samples from end induction-remission bone marrow or blood samples or from buccal swabs, if available
PATIENT CHARACTERISTICS:
Not specified
PRIOR CONCURRENT THERAPY:
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Mullighan, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
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