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Studying Genes in Samples From Younger Patients With Desmoplastic Small Round Cell Tumor Registered on COG-D9902 or COG-ABTR01B1

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01430637
First received: September 7, 2011
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

RATIONALE: Studying samples of blood and 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.

PURPOSE: This research study is studying genes in samples from younger patients with desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.


Condition Intervention
Sarcoma
 Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Other: pharmacogenomic studies

Study Type: Observational
Official Title: Comprehensive Genome Sequencing of Desmoplastic Small Round Cell Tumors

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Identification of novel mutations, single nucleotide polymorphisms, and copy number changes associated with DSRCT [ Designated as safety issue: No ]
  • Identification of genomic regions involved in pathogenesis of DSRCT [ Designated as safety issue: No ]

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

OBJECTIVES:

  • To perform whole-exome sequencing on desmoplastic small round cell tumor (DSRCT) samples and their available matched normal samples to identify novel mutations, single nucleotide polymorphisms, or copy number changes associated with these tumors.
  • To identify regions of interest that may be involved in the pathogenesis (including the region of EWSR1-WT1 translocation) from the whole-exome sequencing and perform detailed resequencing and transcriptone sequencing to further define the molecular aberrations at the RNA level.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for DNA sequencing, effects of RNA on gene expression levels, novel RNA isoforms, splice variants, and translocations.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Tumor and blood samples from patients registered on COG-D9902 or COG-ABTR01B1 obtained from the Cooperative Human Tissue Network (CHTN) and the Children's Oncology Group (COG) tumor banks
  • Matched normal samples

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430637

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pooja Hingorani, MD Phoenix Children's Hospital
  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: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01430637     History of Changes
Other Study ID Numbers: CDR0000710821, COG-ARST11B5
Study First Received: September 7, 2011
Last Updated: September 20, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood desmoplastic small round cell tumor
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
recurrent adult soft tissue sarcoma
 stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
adult desmoplastic small round cell tumor

Additional relevant MeSH terms:
Desmoplastic Small Round Cell Tumor
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 13, 2013