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Status unknownNCT01653613Updated Jul 10, 2013

Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia

An observational study in Leukemia, sponsored by Eastern Cooperative Oncology Group. Status unknown. Open to participants aged 16 Years to 39 Years. Per ClinicalTrials.gov, last updated 2013-07-10.

Sponsored by Eastern Cooperative Oncology Group · Observational

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Enrollment
400
Ages
16 Years to 39 Years
Sex
All
01

Study 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).

Read the 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).

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Conditions studied

  • Leukemia

Keywords

  • B-cell adult acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated childhood acute lymphoblastic leukemia
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 400 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 39 Years
Sexes eligible
All
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
05

Study design

Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • GeneticDNA analysis
  • Geneticfluorescence in situ hybridization
  • Geneticgene expression analysis
  • Geneticmicroarray analysis
  • Geneticmutation analysis
  • Geneticpolymorphism analysis
  • Geneticreverse transcriptase-polymerase chain reaction
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Identification of somatically acquired genetic copy number and sequence alterations

  2. 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

  3. Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01653613
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
First posted
Jul 31, 2012
Start date
Aug 2010
Primary completion
Feb 2013 (estimated)
Last update
Jul 10, 2013

Study contacts

Charles Mullighan, MD
principal investigator · St. Jude Children's Research Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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