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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

Tracking Information
First Submitted Date January 4, 2012
First Posted Date January 6, 2012
Last Update Posted Date May 17, 2017
Actual Study Start Date January 6, 2012
Actual Primary Completion Date February 6, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2017)
  • Comprehensive view of microRNA expression by cytogenetic subgroup [ Time Frame: 1 year ]
  • MicroRNA expression in relation to clinical outcome [ Time Frame: 1 year ]
  • Differential microRNA expression between normal B-cells and progenitors compared to B-ALL [ Time Frame: 1 year ]
Original Primary Outcome Measures
 (submitted: January 4, 2012)
  • Comprehensive view of microRNA expression by cytogenetic subgroup
  • MicroRNA expression in relation to clinical outcome
  • Differential microRNA expression between normal B-cells and progenitors compared to B-ALL
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in Samples From Patients With B-Cell Acute Lymphoblastic Leukemia
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
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.

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
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Samples from patients enrolled on E2993 who provided samples for research
Condition Leukemia
Intervention
  • Genetic: RNA analysis
  • Genetic: cytogenetic analysis
  • Genetic: microarray analysis
  • Other: laboratory biomarker analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2012)
186
Original Estimated Enrollment Same as current
Actual Study Completion Date February 6, 2012
Actual Primary Completion Date February 6, 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01505699
Other Study ID Numbers CDR0000720304
ECOG-E2993T4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eastern Cooperative Oncology Group
Study Sponsor Eastern Cooperative Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Hans-Guido Wendel, MD Memorial Sloan Kettering Cancer Center
PRS Account Eastern Cooperative Oncology Group
Verification Date May 2017