Spots Global Cancer Trial Database for A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
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Trial Identification
Brief Title: A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Official Title: A Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Study ID: NCT01121640
Conditions
Study Description
Brief Summary: The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can be used as a screening method for the early detection of epithelial ovarian cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Stanford University, Stanford, California, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Nicole Urban, ScD
Affiliation: Fred Hutchinson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Beth Karlan, MD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
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