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OpenTrials
Completed

NCT Number: NCT01572467

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

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.

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Key information

Conditions

Childhood Germ Cell Tumor Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Leydig Cell Tumor Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Gonadal Tissue Ovarian Cancer Ovarian Diseases Ovarian Germ Cell Cancer Ovarian Neoplasms Sertoli-Leydig Cell Tumor Sex Cord-Gonadal Stromal Tumors Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RNA analysis

Genetic

gene expression analysis

Genetic

mutation analysis

Genetic

reverse transcriptase-polymerase chain reaction

Genetic

laboratory biomarker analysis

Other

medical chart review

Other

Primary outcomes

  1. Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood

Important dates

Study start
2012
Primary completion
2016
First posted
Apr 6, 2012
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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