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

February 3, 2020 updated by: ECOG-ACRIN Cancer Research Group

Molecular Mechanisms of NOTCH Induced Transformation in T-ALL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

49

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples submitted for research from patients participating in E2993

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Adolfo A. Ferrando, MD, PhD, Herbert Irving Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2006

Primary Completion (Actual)

July 30, 2009

Study Completion (Actual)

July 30, 2009

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000529758
  • ECOG-E2993T2 (Other Identifier: ECOG-ACRIN)
  • R01CA129382 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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