NCT01292733

Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer

Ovarian Cancer Early Detection Screening Program

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.

Detailed description

The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.

Conditions

• Ovarian Diseases
• Ovarian Neoplasms

Interventions

Type	Name	Description
OTHER	Laboratory Tumor Marker Analysis	Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.
OTHER	Transvaginal Ultrasound	Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.
OTHER	Health Status Questionnaire	Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-02-09
• Last updated: 2016-01-20

Locations

1 site across 1 country: United States