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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: April 5, 2012
Last updated: July 13, 2016
Last verified: July 2016

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.

Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis

Estimated Enrollment: 50
Study Start Date: April 2012
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Ovarian or Testicular Sex Cord Stromal Tumors


  • 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


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT01572467

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Dana A. Hill, MD Children's Research Institute
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01572467     History of Changes
Other Study ID Numbers: ARAR12B2
COG-ARAR12B2 ( Other Identifier: Children's Oncology Group )
NCI-2012-00721 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ARAR12B2 ( Other Identifier: Children's Oncology Group )
Study First Received: April 5, 2012
Last Updated: July 13, 2016

Keywords provided by Children's Oncology Group:
Leydig cell tumor
ovarian stromal cancer
childhood malignant testicular germ cell tumor
childhood malignant ovarian germ cell tumor

Additional relevant MeSH terms:
Sertoli-Leydig Cell Tumor
Neoplasms, Germ Cell and Embryonal
Sex Cord-Gonadal Stromal Tumors
Leydig Cell Tumor
Neoplasms by Histologic Type
Neoplasms, Gonadal Tissue
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders processed this record on May 25, 2017