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Clinical Trials/NCT01567046
NCT01567046
Completed
Not Applicable

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

Children's Oncology Group1 site in 1 country70 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Alveolar Soft-part Sarcoma
Sponsor
Children's Oncology Group
Enrollment
70
Locations
1
Primary Endpoint
Genetic changes that are most common and likely to have the greatest therapeutic impact
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Up to 1 month

Frequency of individual mutated genes in patients with NRSTS

Time Frame: Up to 1 month

Study Sites (1)

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