International Ovarian & Testicular Stromal Tumor Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-100
SponsorChildren's Hospitals and Clinics of Minnesota

About this trial

Rare tumors are understudied, yet have the potential to shed light on vast areas of cancer research. Ovarian sex cord-stromal tumors, rare tumors of childhood and young adulthood, have recently been found to be associated with a lung cancer of early childhood called pleuropulmonary blastoma (PPB). The cause of these ovarian tumors is unknown. DICER1 mutations are seen in the majority of children with PPB. Research shows DICER1 mutations are also seen in some patients with ovarian tumors. Like PPB, ovarian stromal tumors are highly curable when found in early stage; however, later forms of the disease are aggressive and often fatal. The International Ovarian Stromal Tumor Registry collects clinical and biologic data to understand why these tumors occur and how to treat them. Current work involves the study of the role of DICER1 and miRNA expression in ovarian stromal tumors. Understanding the clinical history, predisposing factors and DICER1 and miRNA expression in these ovarian tumors of childhood will lead to targeted screening and risk stratification for evidence-based treatment and biologically rational therapies. These efforts will improve the lives of children by increasing survival and reducing late effects.

The specific goals of the International Ovarian and Testicular Stromal Tumor Registry are:

1. to understand risk factors by studying age, pathologic subtype, histopathologic features, tumor invasiveness, degree of differentiation, presence of metastasis 2. to collect information on personal and family history in order to refine the clinical characteristics of patients and families with and without germline DICER1 mutations and other genetic predisposing factors 3. to determine whether there is a pattern of gene expression or DNA alterations that correlate with predisposition to ovarian tumors, biologic behavior and clinical outcome 4. to determine optimal screening regimens 5. to use clinical data obtained through the Registry to refine treatment algorithms 6. to establish a collection of annotated biology specimens (tumor tissue and germline DNA) for future research

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Previous or current diagnosis of an ovarian sex cord stromal including but not limited to: Sertoli-Leydig cell tumor, gynandroblastoma (now enrolling these patients on PPB/DICER1 Registry), juvenile granulosa cell tumor, Sertoli cell tumor, sex cord-stromal tumor with annular tubules or undifferentiated stromal tumor

Previous or current diagnosis of a testicular stromal tumor including but not limited to: juvenile granulosa cell tumor, Sertoli cell tumor, Leydig cell tumor or undifferentiated stromal tumor

Disqualifiers

Unable to provide informed consent/assent

Adult Granulosa cell tumor (unless otherwise specified by Medical Director)

Trial population

Prospectively or retrospectively diagnosed patients with ovarian or testicular stromal tumors or ovarian small cell carcinoma

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 3 trial groups
Group A: Ovarian Stromal Tumors
Group B: Testicular Stromal Tumors
Group C: Ovarian Small Cell Carcinoma

Trial outcomes

Primary outcomes

1

DICER1 mutations in ovarian and testicular stromal tumors

We will analyze germline DNA from patients with gonadal stromal tumors to determine the presence of DICER1 mutations. The tumor tissue will also be sequenced. mRNA and miRNA expression will be analyzed on tumor tissue. Results of the above will be correlated with clinical outcome.

Time frame
3 years

Secondary outcomes

1

Clinical factors associated with outcome in ovarian and testicular stromal tumors

We will analyze the clinical records to determine which factors influence prognosis

Time frame
10 years
2

Pathologic and Genetic Correlations

We will correlate the pathologic and genetic data with clinical data to describe factors associated with poor prognosis.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospitals and Clinics of Minnesota

Lead sponsor

Children's National Research Institute

Collaborator

Dana-Farber Cancer Institute

Collaborator

Washington University School of Medicine

Collaborator

University of Texas Southwestern Medical Center

Collaborator

M.D. Anderson Cancer Center

Collaborator

Children's Hospital Colorado

Collaborator

Rutgers University

Collaborator

Massachusetts General Hospital

Collaborator

Klinikum Dortmund Wirbelsäulenchirurgie

Collaborator

ResourcePath, LLC

Collaborator

Allina Health System

Collaborator

Phoenix Children's Hospital

Collaborator

University of Cambridge

Collaborator