NCT01572467

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

4.3 years

First QC Date

April 5, 2012

Last Update Submit

July 13, 2016

Conditions

Keywords

Leydig cell tumorovarian stromal cancerchildhood malignant testicular germ cell tumorchildhood malignant ovarian germ cell tumor

Outcome Measures

Primary Outcomes (1)

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

Interventions

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients With Ovarian or Testicular Sex Cord Stromal Tumors

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Leydig Cell TumorOvarian NeoplasmsTesticular NeoplasmsOvarian Germ Cell Cancer

Interventions

Gene Expression ProfilingReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Sertoli-Leydig Cell TumorSex Cord-Gonadal Stromal TumorsNeoplasms, Gonadal TissueNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, Female

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Dana A. Hill, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 6, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07