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NCT01505699 Clinical Trial

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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01505699
Other study ID # CDR0000720304
Secondary ID ECOG-E2993T4
Status Completed
Phase N/A
First received January 4, 2012
Last updated May 16, 2017
Start date January 6, 2012
Est. completion date February 6, 2012

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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date February 6, 2012
Est. primary completion date February 6, 2012
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA analysis

• cytogenetic analysis

• microarray analysis

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eastern Cooperative Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Comprehensive view of microRNA expression by cytogenetic subgroup 1 year
Primary MicroRNA expression in relation to clinical outcome 1 year
Primary Differential microRNA expression between normal B-cells and progenitors compared to B-ALL 1 year
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