Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.
PURPOSE: Screening trial to determine the significance of cancer antigen 125 (CA125) levels in detecting ovarian cancer in participants who have a high genetic risk of developing ovarian cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Ovarian Cancer Screening Pilot Trial in High Risk Women|
- Sensitivity of early detection for ovarian cancer [ Time Frame: Up to one year since last blood test ] [ Designated as safety issue: No ]
- Specificity of early detection [ Time Frame: Up to one year from last blood test ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Other: Early detection
CA125 is measured in blood and the longitudinal results interpreted with a statistical algorithm to determine if there has been a significant increase from baseline.
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|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Steven J. Skates, PhD||Massachusetts General Hospital|