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

Completed

• Conditions: Childhood Alveolar Soft-part Sarcoma; Childhood Leiomyosarcoma; Childhood Liposarcoma; Childhood Neurofibrosarcoma; Childhood Synovial Sarcoma; Chordoma; Recurrent Childhood Soft Tissue Sarcoma; Childhood Desmoplastic Small Round Cell Tumor; Childhood Epithelioid Sarcoma; Childhood Malignant Mesenchymoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01567046
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-30
• Status Verified: 2016-05
• Study Start: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlative studies	laboratory biomarker analysis	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States