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NCT01430637 Clinical Trial

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

Sarcoma Clinical Trial

Official title:
Comprehensive Genome Sequencing of Desmoplastic Small Round Cell Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01430637
Other study ID # ARST11B5
Secondary ID COG-ARST11B5ARST
Status Completed
Phase N/A
First received September 7, 2011
Last updated May 17, 2016
Start date September 2011

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 50 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Desmoplastic Small Round Cell Tumor
  • Sarcoma

Intervention

Genetic:
• DNA analysis

• RNA analysis

• gene expression analysis

• mutation analysis

• nucleic acid sequencing

• polymerase chain reaction

Other:
• laboratory biomarker analysis

• pharmacogenomic studies

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of novel mutations, single nucleotide polymorphisms, and copy number changes associated with DSRCT No
Primary Identification of genomic regions involved in pathogenesis of DSRCT No
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