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DNA Analysis of Tissue From Patients With T-Cell Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00899366
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Description
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Brief Summary:

RATIONALE: Studying samples of tissue 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 laboratory study is looking at tissue samples from patients with T-cell acute lymphoblastic leukemia.


Condition or disease Intervention/treatment
Leukemia Genetic: microarray analysis Genetic: mutation analysis Other: immunologic technique

Detailed Description:

OBJECTIVES:

  • Identify the transcriptional signatures associated with the presence of NOTCH1 mutations in primary T-cell acute lymphoblastic leukemia (T-ALL) cells using oligonucleotide microarrays.
  • Characterize the global changes on gene expression resulting from the inactivation of NOTCH signaling in human T-ALL lymphoblasts.

OUTLINE: This is a multicenter study.

Frozen lymphoblast samples from patients with T-cell acute lymphoblastic leukemia (NOTCH1-mutated and wild type) are assessed for genetic expression profiles and mutations by microarray analysis and activated NOTCH1 protein by western blot analysis.

PROJECTED ACCRUAL: A total of 48 samples from patients will be accrued for this study.

Study Design
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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Molecular Mechanisms of NOTCH Induced Transformation in T-ALL
Actual Study Start Date : December 28, 2006
Actual Primary Completion Date : July 30, 2009
Actual Study Completion Date : July 30, 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Transcriptional signatures associated with NOTCH1 mutations in T-cell acute lymphoblastic leukemia (T-ALL) cells [ Time Frame: 1 month ]
    Mutational analysis

  2. Global changes on gene expression resulting from inactivation of NOTCH signaling in T-ALL cells [ Time Frame: 1 month ]
    Gene expression


Biospecimen Retention:   Samples With DNA
bone marrow and blood nucleic acids and cells.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients participating in E2993
Criteria

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of T-cell acute lymphoblastic leukemia

  • Frozen lymphoblast samples available

    • NOTCH1-mutated or wild type sample available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Exclusion Criteria:

  • Not applicable
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00899366


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Adolfo A. Ferrando, MD, PhD Herbert Irving Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00899366    
Other Study ID Numbers: CDR0000529758
ECOG-E2993T2 ( Other Identifier: ECOG-ACRIN )
R01CA129382 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: May 2017
Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
T-cell adult acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
 recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases