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Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01342783
First received: April 23, 2011
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.


Condition Intervention
Sarcoma
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: mutation analysis
Genetic: nucleic acid sequencing
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Next Generation Sequencing of Childhood Soft Tissue Sarcomas to Identify Drivers of Primary and Metastatic Disease

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Occurrence of somatic mutations in driver genes and mutations in other genes that occur individually [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2011
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
  • To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.

OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COG-D9902 soft tissue sarcoma biology and banking study participants.
Criteria

DISEASE CHARACTERISTICS:

  • Banked childhood samples from the COG-D9902 soft tissue sarcoma biology and banking study
  • Rhabdomyosarcoma, NOS

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT01342783

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Poul Sorensen, MD, PhD British Columbia Cancer Agency
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01342783     History of Changes
Other Study ID Numbers: ARST11B2  COG-ARST11B2  NCI-2011-02853  ARST11B2 
Study First Received: April 23, 2011
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on December 09, 2016