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Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342783
First Posted: April 27, 2011
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: Children's Oncology Group )
NCI-2011-02853 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ARST11B2 ( Other Identifier: Children's Oncology Group )
First Submitted: April 23, 2011
First Posted: April 27, 2011
Last Update Posted: May 18, 2016
Last Verified: May 2016

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