Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01572467
First received: April 5, 2012
Last updated: May 11, 2015
Last verified: May 2015

April 5, 2012
May 11, 2015
April 2012
January 2100   (final data collection date for primary outcome measure)
Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01572467 on ClinicalTrials.gov Archive Site
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Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors
DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood

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

PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.

OBJECTIVES:

  • To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.

OUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Patients With Ovarian or Testicular Sex Cord Stromal Tumors

  • Childhood Germ Cell Tumor
  • Leydig Cell Tumor
  • Ovarian Cancer
  • Genetic: RNA analysis
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Other: medical chart review
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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January 2100   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Fixed and frozen tissue samples from the ATBR01 B1 tissue bank and from the International Pleuropulmonary Blastoma Registry, Children's Hospital of Boston, and Massachusetts General Hospital
  • Tissue samples from patients diagnosed with:

    • Ovarian

      • Sertoli-Leydig cell tumor
      • Juvenile granulosa cell tumor
      • Adult granulosa cell tumor
      • Gynandroblastoma
      • Sex cord stromal tumor with annular tubules
      • Sex cord stromal tumor, undifferentiated
      • Sertoli tumor
      • Leydig tumor
    • Testicular:

      • Granulosa cell tumor
      • Sertoli tumor
      • Leydig tumor
      • Sertoli-Leydig
      • Undifferentiated stromal tumor

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01572467
ARAR12B2, COG-ARAR12B2, NCI-2012-00721, ARAR12B2
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Dana A. Hill, MD Children's Research Institute
Children's Oncology Group
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP