Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass
The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers|
- The risk of malignancy in the presence of pelvic mass demonstrated by sonography. [ Time Frame: Up to 2 months after recruiting and examining the last participant of the study ] [ Designated as safety issue: Yes ]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.
- number and kind of operative complications [ Time Frame: within one month after operation ] [ Designated as safety issue: Yes ]Information about operative complications will be collected from the files of participants who were operated
- Reasons for intervention [ Time Frame: within one month after operation ] [ Designated as safety issue: No ]The reasons that led the treating physician to choose a surgical treatment will be collected from the files of the participants who were operated
- operative finding and histologic results [ Time Frame: within one month after operation ] [ Designated as safety issue: No ]The operative finding and histologic results will be collected from the files of the participants who were operated
|Study Start Date:||May 2011|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
women, sonographic ovarian mass
women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477788
|Sonographic unit, Department of Ob/Gyn, Haemek medical center|
|Principal Investigator:||yfat kadan, MD||Department of Ob/Gyn, Haemek medical center, Afula Israel|