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

May 16, 2017 updated by: Eastern Cooperative Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

32

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples from patient enrolled on E2404 from whom samples were submitted for research

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New somatically mutated genes in T-cell and NK lymphoma samples
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Adolfo A. Ferrando, MD, PhD, Herbert Irving Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2011

Primary Completion (Actual)

August 28, 2011

Study Completion (Actual)

August 28, 2011

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000703260
  • ECOG-E2404T1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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