Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers
Patients that arrive to the sonographic unit of the gynecological department with a
diagnosis of ovarian mass will have a sonographic examination that include: Trans-vaginal +-
trans-abdominal ultrasound with Doppler and three dimensional sonographic exam. anamnestic
data will be collected and serum test for CA 125, HE4 and CEA. The management of the
specific patient will be according to the department protocol, regardless the study data.
The investigators will collect data about operation outcome and histological results of
women that will be operated. Women that won't be operated on will be followed up every 6
months by the study team.
At the end of the study a statistical analysis will be made to create a sensitive and
specific test for the prediction of malignancy in sonographic diagnosed ovarian mass.
Observational
Observational Model: Cohort, Time Perspective: Retrospective
The risk of malignancy in the presence of pelvic mass demonstrated by sonography.
Using a combination of the results of US examination, patient's history and serum markers to predict the risk of malignancy in women with pelvic mass demonstrated by sonography.
Up to 2 months after recruiting and examining the last participant of the study
Yes
yfat kadan, MD
Principal Investigator
Department of Ob/Gyn, Haemek medical center, Afula Israel
Israel: Ministry of Health
EMC-0083-09
NCT01477788
May 2011
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