Studying Genes in Samples From Younger Patients With Ovar... | NCT01572467

ID	Type	Description
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

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Apr 5, 2012

First Submission Date that Met QC Criteria

Apr 5, 2012

First Posted Date

Apr 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RNA analysis	Genetic
gene expression analysis	Genetic
mutation analysis	Genetic
reverse transcriptase-polymerase chain reaction	Genetic
laboratory biomarker analysis	Other
medical chart review	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients With Ovarian or Testicular Sex Cord Stromal Tumors

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Dana A. Hill, MD	Children's National Research Institute	Principal Investigator

ID	Term
D007984	Leydig Cell Tumor
D010051	Ovarian Neoplasms
D013736	Testicular Neoplasms
C562841	Ovarian Germ Cell Cancer

Ancestor Terms

ID	Term
D018310	Sertoli-Leydig Cell Tumor
D018312	Sex Cord-Gonadal Stromal Tumors
D018309	Neoplasms, Gonadal Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D004700	Endocrine System Diseases
D013733	Testicular Diseases
D006058	Gonadal Disorders
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D005833	Genital Neoplasms, Female

ID	Term
D020869	Gene Expression Profiling
D020133	Reverse Transcriptase Polymerase Chain Reaction

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques