Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00039559|
Recruitment Status : Unknown
Verified June 2013 by Steven Skates, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : June 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Other: Early detection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2430 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ovarian Cancer Screening Pilot Trial in High Risk Women|
|Study Start Date :||May 2002|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
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.
- Sensitivity of early detection for ovarian cancer [ Time Frame: Up to one year since last blood test ]
- Specificity of early detection [ Time Frame: Up to one year from last blood test ]
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): NCT00039559
|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|