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Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01342783
First received: April 23, 2011
Last updated: May 25, 2011
Last verified: May 2011
History of Changes
  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
Official Title: Next Generation Sequencing of Childhood Soft Tissue Sarcomas to Identify Drivers of Primary and Metastatic Disease

Resource links provided by NLM:

U.S. FDA Resources

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

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
Estimated Primary Completion Date: August 2011 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01342783     History of Changes
Other Study ID Numbers: CDR0000699508, COG-ARST11B2
Study First Received: April 23, 2011
Last Updated: May 25, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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 May 22, 2013