Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas

May 13, 2016 updated by: Children's Oncology Group

Observational - Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

This research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas. 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 cancer

Study Overview

Detailed Description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Existing NRSTS samples from the COG D9902/ARST0332 studies Sampling Method: Non-Probability Sample

OBJECTIVES:

I. To determine the frequency with which actionable mutations are found in archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor specimens using mass spectrometry (MS) analysis of tumor-derived deoxyribonucleic acid (DNA).

OUTLINE:

Archived DNA tissue samples are analyzed for frequency of genetic mutations, including single nucleotide polymorphisms (SNPs), single nucleotide variants (SNVs), and small deletions and/or insertions, by polymerase chain reaction (PCR) and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Monrovia, California, United States, 91006-3776
        • Children's Oncology Group

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

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-rhabdomyosarcoma soft tissue sarcoma

Description

Inclusion Criteria:

  • Archived non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) tumor-derived DNA

    • Synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST), soft tissue sarcoma not otherwise specified (NOS), or other less common pediatric NRSTS
    • Formalin-fixed, paraffin-embedded (FFPE) tissue from patients enrolled on:

      • COG-D9902 Soft Tissue Sarcoma (STS) Biology and Banking Protocol
      • COG-ARST0332 A Risk-Based Treatment for Pediatric NRSTS Study
  • 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Correlative studies
Archived DNA tissue samples are analyzed for frequency of genetic mutations, including SNPs, SNVs, and small deletions and/or insertions, by PCR and mass spectometry (Sequenom MassARRAY). Results are then analyzed to determine whether specific mutations correlate with patient or disease features such as tumor stage, histological grade, or outcome.
Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of individual mutated genes in patients with NRSTS
Time Frame: Up to 1 month
Up to 1 month
Genetic changes that are most common and likely to have the greatest therapeutic impact
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Steve Skapek, MD, Children's Oncology Group

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

May 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

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.

Clinical Trials on Chordoma

Clinical Trials on laboratory biomarker analysis

3
Subscribe