Recruiting

Observational Study

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT01970696

Conditions

Ovarian Sex-cord Stromal Tumor

Testicular Stromal Tumors

Ovarian Small Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Ovarian Sex-cord Stromal Tumor

Testicular Stromal Tumors

Ovarian Small Cell Carcinoma

Study ID

NCT01970696

Start date

Dec 8, 2011

Status verified date

Aug, 2024

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unable to provide informed consent/assent
  • Adult Granulosa cell tumor (unless otherwise specified by Medical Director)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Ovarian Stromal Tumors

Testicular Stromal Tumors

Ovarian Small Cell Carcinoma

Primary outcome measure

  • DICER1 mutations in ovarian and testicular stromal tumors [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Children's Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Kris Ann P Schultz, MD

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Keywords

  • ovarian
  • testicular
  • stromal
  • sertoli
  • leydig
  • juvenile granulosa cell tumor
  • gynandroblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2024-08-22.