RECRUITING

International Ovarian & Testicular Stromal Tumor Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

International Ovarian & Testicular Stromal Tumor Registry

Quick Facts

Study Start:2011-12-08
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01970696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  1. * Unable to provide informed consent/assent
  2. * Adult Granulosa cell tumor (unless otherwise specified by Medical Director)

Contacts and Locations

Study Contact

Anne Harris, MPH
CONTACT
612-813-5861
anne.harris@childrensmn.org
Paige Mallinger, MS
CONTACT
612-813-7121
paige.mallinger@childrensmn.org

Principal Investigator

Kris Ann P Schultz, MD
PRINCIPAL_INVESTIGATOR
Children's Minnesota

Study Locations (Sites)

Children's Minnesota
Minneapolis, Minnesota, 55404
United States

Collaborators and Investigators

Sponsor: Children's Hospitals and Clinics of Minnesota

  • Kris Ann P Schultz, MD, PRINCIPAL_INVESTIGATOR, Children's Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-12-08
Study Completion Date2030-12

Study Record Updates

Study Start Date2011-12-08
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Ovarian Sex-cord Stromal Tumor
  • Testicular Stromal Tumors
  • Ovarian Small Cell Carcinoma