Biomarkers in Samples From Patients With B-Cell Acute Lymphoblastic Leukemia

May 16, 2017 updated by: Eastern Cooperative Oncology Group

Micro RNA Expression Analysis in B-Lineage Adult Acute Lymphoblastic Leukemia From ALL Trial, E2993, Including Patients With Various Cytogenetic and Molecular Abnormalities

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with acute lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.

Study Overview

Status

Completed

Conditions

Leukemia

Intervention / Treatment

Detailed Description

OBJECTIVES:

To identify microRNAs that behave as oncogenes or as tumor suppressor genes in B-lineage acute lymphoblastic leukemia (ALL) in vitro and in vivo.
To examine if single microRNA or signatures of microRNA correspond to different clinical outcomes in cytogenetically distinct B-ALL groups.

OUTLINE: RNA from archived samples are analyzed for microRNA expression profile in vitro and in vivo.

Study Type

Observational

Enrollment (Actual)

186

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

15 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples from patients enrolled on E2993 who provided samples for research

Description

DISEASE CHARACTERISTICS:

Samples from patients enrolled on ECOG-2993
Samples from patients with recurrent cytogenetic abnormalities other than BCR-ABL, including MLL/AF4, E2A/PBX1, and TEL/AML1

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

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	Time Frame
Comprehensive view of microRNA expression by cytogenetic subgroup Time Frame: 1 year	1 year
MicroRNA expression in relation to clinical outcome Time Frame: 1 year	1 year
Differential microRNA expression between normal B-cells and progenitors compared to B-ALL Time Frame: 1 year	1 year

Collaborators and Investigators

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

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Hans-Guido Wendel, MD, Memorial Sloan Kettering Cancer Center

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)

January 6, 2012

Primary Completion (ACTUAL)

February 6, 2012

Study Completion (ACTUAL)