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NCT00899366 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Molecular Mechanisms of NOTCH Induced Transformation in T-ALL

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00899366
Other study ID # CDR0000529758
Secondary ID ECOG-E2993T2R01C
Status Completed
Phase
First received
Last updated
Start date December 28, 2006
Est. completion date July 30, 2009

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date July 30, 2009
Est. primary completion date July 30, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• microarray analysis

• mutation analysis

Other:
• immunologic technique

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Transcriptional signatures associated with NOTCH1 mutations in T-cell acute lymphoblastic leukemia (T-ALL) cells Mutational analysis 1 month
Primary Global changes on gene expression resulting from inactivation of NOTCH signaling in T-ALL cells Gene expression 1 month
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