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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01567046
First received: March 27, 2012
Last updated: March 31, 2012
Last verified: March 2012
History of Changes

March 27, 2012
March 31, 2012
March 2012
May 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
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
Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

RATIONALE: 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.

PURPOSE: This research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas.

OBJECTIVES:

  • 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
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  • Chordoma
  • Desmoid Tumor
  • Sarcoma
  • Genetic: DNA analysis
  • Genetic: microarray analysis
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Other: mass spectrometry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
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May 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
up to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01567046
CDR0000729355, COG-ARST12B5
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Peter C. Adamson, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Steve Skapek, MD University of Texas Southwestern Medical Center at Dallas
National Cancer Institute (NCI)
March 2012

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