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Trial record 3 of 5 for:    "Sertoli-leydig cell tumors"
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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:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01572467
First received: April 5, 2012
Last updated: April 7, 2012
Last verified: April 2012
History of Changes
  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
Official Title: DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Primary Completion Date: June 2012 (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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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: NCT01572467     History of Changes
Other Study ID Numbers: CDR0000730091, COG-ARAR12B2
Study First Received: April 5, 2012
Last Updated: April 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Leydig Cell Tumor
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Sex Cord-Gonadal Stromal Tumors
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Neoplasms
Testicular Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on May 16, 2013