Cancer Screening Program for Women at High Risk for Developing Ovarian Cancer (OCEDP)
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|ClinicalTrials.gov Identifier: NCT01292733|
Recruitment Status : Terminated (Closed per local IRB due to advancements in standard ovarian cancer screening.)
First Posted : February 9, 2011
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Diseases Ovarian Neoplasms||Other: Laboratory Tumor Marker Analysis Other: Transvaginal Ultrasound Other: Health Status Questionnaire||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||534 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ovarian Cancer Early Detection Screening Program|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Ovarian Cancer Screening
CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires
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.
- Measuring for elevated levels of tumor marker CA-125 in the blood over time. [ Time Frame: Average expected time of 1 year ]
- Performing transvaginal ultrasounds to look for any abnormalities over time. [ Time Frame: Average expected time of 1 year ]Criteria for an abnormal scan include 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. Volume calculations will determine whether the ovary is enlarged.
- Performing health status questionnaires over time [ Time Frame: Average expected time of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292733
|United States, Washington|
|Marsha Rivkin Center for Ovarian Cancer Research|
|Seattle, Washington, United States, 98122|
|Principal Investigator:||Pamela Paley, MD||Swedish Medical Center|