Biomarkers in Tumor Tissue Samples From Patients With Peripheral T-cell Lymphoma or Natural Killer Cell Neoplasms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01390597
First received: July 7, 2011
Last updated: July 12, 2011
Last verified: July 2011

July 7, 2011
July 12, 2011
August 2011
September 2011   (final data collection date for primary outcome measure)
  • New somatically mutated genes in T-cell and NK lymphoma samples [ Designated as safety issue: No ]
  • Prognostic significance of mutations in genes and pathways with cell proliferation, survival, and response to epigenetic therapy [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01390597 on ClinicalTrials.gov Archive Site
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Biomarkers in Tumor Tissue Samples From Patients With Peripheral T-cell Lymphoma or Natural Killer Cell Neoplasms
The Molecular Mechanisms of Transformation in Peripheral T-cell and NK Lymphomas

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

PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with peripheral T-cell lymphoma or natural killer cell neoplasms.

OBJECTIVES:

  • To identify mutations in oncogenes and tumor suppressors of peripheral T-cell lymphoma or natural killer (NK) cell neoplasm.
  • To delineate the mechanisms that mediate oncogenic effects and their clinical prognostic significance in these diseases.
  • To perform a comprehensive mutation analysis via whole exome resequencing in a panel of peripheral T-cell or NK lymphomas.

OUTLINE: Fixed paraffin-embedded tumor tissue samples are analyzed for mutations by the Illumina HiSeq platform. Sequencing reads are performed by GAPipeline version 1.5.1 and mapping on the human genome performed using the MAQ software version 0.7.1. Genes harboring validated somatic mutations are then amplified by PCR and analyzed by Sanger resequencing.

Observational
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Lymphoma
  • Genetic: DNA analysis
  • Genetic: cytogenetic analysis
  • Genetic: gene mapping
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
32
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September 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosed with peripheral T-cell lymphoma or natural killer cell neoplasms
  • Available fresh tumor samples from patients treated on ECOG-E2404 and normal DNA (non-ECOG) samples

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
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NCT01390597
CDR0000703260, ECOG-E2404T1
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Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Adolfo A. Ferrando, MD, PhD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP