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NCT01567046 Clinical Trial

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

Chordoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01567046
Other study ID # ARST12B5
Secondary ID NCI-2012-00714
Status Recruiting
Phase N/A
First received March 27, 2012
Last updated November 6, 2015
Start date March 2012

Study information
Verified date November 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Childhood Alveolar Soft-part Sarcoma
  • Childhood Angiosarcoma
  • Childhood Desmoplastic Small Round Cell Tumor
  • Childhood Epithelioid Sarcoma
  • Childhood Fibrosarcoma
  • Childhood Leiomyosarcoma
  • Childhood Liposarcoma
  • Childhood Malignant Mesenchymoma
  • Childhood Neurofibrosarcoma
  • Childhood Synovial Sarcoma
  • Chordoma
  • Desmoid Tumor
  • Desmoplastic Small Round Cell Tumor
  • Fibrosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Liver Neoplasms
  • Metastatic Childhood Soft Tissue Sarcoma
  • Nonmetastatic Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Sarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma, Synovial

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of individual mutated genes in patients with NRSTS Up to 1 month No
Primary Genetic changes that are most common and likely to have the greatest therapeutic impact Up to 1 month No
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