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

July 13, 2016 updated by: Children's Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients With Ovarian or Testicular Sex Cord Stromal Tumors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Dana A. Hill, MD, Children's National Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARAR12B2 (Other Identifier: Children's Oncology Group)
  • COG-ARAR12B2 (Other Identifier: Children's Oncology Group)
  • NCI-2012-00721 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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