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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01572467
First Posted: April 6, 2012
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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:

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.

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572467


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov 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 )
First Submitted: April 5, 2012
First Posted: April 6, 2012
Last Update Posted: July 14, 2016
Last Verified: July 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
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