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

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01567046
Collaborator
National Cancer Institute (NCI) (NIH)
70
1

Study Details

Study Description

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:
  1. 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 Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Observational - Potentially Actionable Mutations in Archived Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)
Study Start Date :
May 1, 2016
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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.

Other: laboratory biomarker analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. Frequency of individual mutated genes in patients with NRSTS [Up to 1 month]

  2. Genetic changes that are most common and likely to have the greatest therapeutic impact [Up to 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Oncology Group Monrovia California United States 91006-3776

Sponsors and Collaborators

  • Children's Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Steve Skapek, MD, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01567046
Other Study ID Numbers:
  • ARST12B5
  • NCI-2012-00714
First Posted:
Mar 30, 2012
Last Update Posted:
May 17, 2016
Last Verified:
May 1, 2016

Study Results

No Results Posted as of May 17, 2016