Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Gene Expression in Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01520246
First received: January 26, 2012
Last updated: July 7, 2016
Last verified: July 2016
  Purpose

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from patients with T-cell acute lymphoblastic leukemia.


Condition Intervention
Leukemia
Lymphoma
Genetic: gene expression analysis
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Signaling in Tumorigenesis and Immunity

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • PDLIM2 expression patterns in cancer and control tissues [ Designated as safety issue: No ]
  • 8-week survival of human T-cell co-cultured with HTLV-1-transformed T-cell lines [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
tissue, blood, and bodily fluids

Estimated Enrollment: 20
Study Start Date: January 2012
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To test whether the tumor suppressor candidate gene PDLIM2 is downregulated in human cancers such as T-cell acute lymphoblastic leukemia (T-ALL) and to use the human T-lymphotropic virus 1 (HTLV-1)-mediated in vitro transformation of human T cells as control.

OUTLINE: Previously collected cancer and control tissues are analyzed for the expression patterns of PDLIM2 and other control genes. Human T-cells isolated from human blood are also co-cultured with HTLV-1-transformed T-cell lines.

  Eligibility

Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With T-Cell Acute Lymphoblastic Leukemia
Criteria

DISEASE CHARACTERISTICS:

  • Specimens (e.g., tissue, blood, and bodily fluids) of various cancer cells and or tissues from de-identified patients such as T-cell acute lymphoblastic leukemia (T-ALL)
  • Normal control tissue

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520246

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gutian Xiao, MD University of Pittsburgh
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01520246     History of Changes
Other Study ID Numbers: AALL12B2  COG-AALL12B2  CDR0000723902  AALL12B2  NCI-2012-00241 
Study First Received: January 26, 2012
Last Updated: July 7, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia
adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on December 05, 2016