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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
Chordoma
Desmoid Tumor
Sarcoma
Genetic: DNA analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Other: mass spectrometry

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: March 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567046

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Steve Skapek, MD University of Texas Southwestern Medical Center at Dallas
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01567046     History of Changes
Other Study ID Numbers: CDR0000729355, COG-ARST12B5
Study First Received: March 27, 2012
Last Updated: March 31, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood alveolar soft-part sarcoma
childhood angiosarcoma
childhood epithelioid sarcoma
childhood fibrosarcoma
childhood leiomyosarcoma
childhood liposarcoma
childhood neurofibrosarcoma
childhood synovial sarcoma
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
chordoma
childhood desmoplastic small round cell tumor
desmoid tumor
childhood malignant mesenchymoma

Additional relevant MeSH terms:
Chordoma
Fibromatosis, Aggressive
Sarcoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on August 26, 2014