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NCT01572467 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01572467
Other study ID # ARAR12B2
Secondary ID COG-ARAR12B2NCI-
Status Completed
Phase N/A
First received April 5, 2012
Last updated July 13, 2016
Start date April 2012

Study information
Verified date July 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA analysis

• gene expression analysis

• mutation analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis No
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