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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01567046
First received: March 27, 2012
Last updated: May 6, 2015
Last verified: May 2015

March 27, 2012
May 6, 2015
March 2012
January 2100   (final data collection date for primary outcome measure)
  • Frequency of individual mutated genes in patients with NRSTS [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Genetic changes that are most common and likely to have the greatest therapeutic impact [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • Frequency of individual mutated genes in patients with NRSTS [ Designated as safety issue: No ]
  • Genetic changes that are most common and likely to have the greatest therapeutic impact [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01567046 on ClinicalTrials.gov Archive Site
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Studying Genes in Tissue Samples From Younger and Adolescent Patients With Soft Tissue Sarcomas
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 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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue

Non-Probability Sample

Non-rhabdomyosarcoma soft tissue sarcoma

  • 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
  • Metastatic Childhood Soft Tissue Sarcoma
  • Nonmetastatic Childhood Soft Tissue Sarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
Other: laboratory biomarker analysis
Correlative studies
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.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
up to 30 Years
No
United States
 
NCT01567046
ARST12B5, NCI-2012-00714
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Steve Skapek, MD Children's Oncology Group
Children's Oncology Group
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP