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

Lymphoma Clinical Trial

Official title:

The Molecular Mechanisms of Transformation in Peripheral T-cell and NK Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390597
• Other study ID #: CDR0000703260
• Secondary ID: ECOG-E2404T1
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: May 16, 2017
• Start date: June 28, 2011
• Est. completion date: August 28, 2011

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 28, 2011
• Est. primary completion date: August 28, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell, Peripheral

Intervention

Genetic:
• DNA analysis

• cytogenetic analysis

• gene mapping

• mutation analysis

• polymerase chain reaction

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	New somatically mutated genes in T-cell and NK lymphoma samples		1 year