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
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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 |
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 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 |

- Transcriptional signatures associated with NOTCH1 mutations in T-cell acute lymphoblastic leukemia (T-ALL) cells [ Time Frame: 1 month ]Mutational analysis
- 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

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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 |
DISEASE CHARACTERISTICS:
- Confirmed diagnosis of T-cell acute lymphoblastic leukemia
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Frozen lymphoblast samples available
- NOTCH1-mutated or wild type sample available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Exclusion Criteria:
- Not applicable

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
Study Chair: | Adolfo A. Ferrando, MD, PhD | Herbert Irving Comprehensive Cancer Center |
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 |
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 |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |