Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
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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. 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).
| Condition | Intervention |
|---|---|
|
Leukemia |
Genetic: DNA analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymorphism analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia |
- Identification of somatically acquired genetic copy number and sequence alterations [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 16 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01653613 History of Changes |
| Other Study ID Numbers: | CDR0000737435, ECOG-E2L10T1 |
| Study First Received: | July 27, 2012 |
| Last Updated: | July 27, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
B-cell adult acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013