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

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ClinicalTrials.gov Identifier: NCT01505699
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Leukemia Genetic: RNA analysis Genetic: cytogenetic analysis Genetic: microarray analysis Other: laboratory biomarker analysis

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 Design
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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : January 6, 2012
Actual Primary Completion Date : February 6, 2012
Actual Study Completion Date : February 6, 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Comprehensive view of microRNA expression by cytogenetic subgroup [ Time Frame: 1 year ]
  2. MicroRNA expression in relation to clinical outcome [ Time Frame: 1 year ]
  3. Differential microRNA expression between normal B-cells and progenitors compared to B-ALL [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients enrolled on E2993 who provided samples for research
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01505699


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hans-Guido Wendel, MD Memorial Sloan Kettering Cancer Center
More Information
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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01505699    
Other Study ID Numbers: CDR0000720304
ECOG-E2993T4
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Keywords provided by Eastern Cooperative Oncology Group:
adult acute lymphoblastic leukemia in remission
B-cell adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases