NCT01970696 International Ovarian & Testicular Stromal Tumor Registry
| NCT ID | NCT01970696 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospitals and Clinics of Minnesota |
| Condition | Ovarian Sex-cord Stromal Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2011-12-08 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2011-12-08 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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)
Contact & Investigator
Kris Ann P Schultz, MD
PRINCIPAL INVESTIGATOR
Children's Minnesota
Frequently Asked Questions
Who can join the NCT01970696 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying Ovarian Sex-cord Stromal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01970696 currently recruiting?
Yes, NCT01970696 is actively recruiting participants. Contact the research team at anne.harris@childrensmn.org for enrollment information.
Where is the NCT01970696 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT01970696 clinical trial?
NCT01970696 is sponsored by Children's Hospitals and Clinics of Minnesota. The principal investigator is Kris Ann P Schultz, MD at Children's Minnesota. The trial plans to enroll 300 participants.