A Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Epithelial ovarian cancer (EOC) is usually lethal unless it is diagnosed at an early stage,
thus early detection is likely to play an important role in reducing its mortality. Within
the Ovarian Specialized Programs of Research Excellence Pacific Ovarian Cancer Research
Consortium (POCRC) researchers have been working for a decade to discover, develop, and
validate biomarkers (proteins or substances found in blood) that could help save lives by
detecting EOC early. During the last five years several biomarkers, including CA125, have
been evaluated for their ability to detect EOC at an earlier stage. The best markers will
now be studied in a new randomized controlled trial of ovarian cancer screening.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Positive predictive value of each of the two screening protocols
Calculated as number of women with a significant lesion identified at a protocol-indicated procedure divided by number of women with protocol-indicated surgical procedures performed.
From first screen through remaining study period
No
Nicole Urban, ScD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Institutional Review Board
P50CA83636-01
NCT01121640
November 2009
June 2014
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Stanford University | Stanford, California 94305 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
City of Hope | Duarte, California 91010 |