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NCT Number: NCT01567046

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Frequency of individual mutated genes in patients with NRSTS

    Time frame: Up to 1 month

  2. Genetic changes that are most common and likely to have the greatest therapeutic impact

    Time frame: Up to 1 month

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2012
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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