Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers

Conditions
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Ovarian Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred with sonographic diagnosis of pelvic mass Exclusion Criteria: Pregnant women Known gynecologic malignancy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women, sonographic ovarian mass<br>women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number and kind of operative complications | Information about operative complications will be collected from the files of participants who were operated | within one month after operation | 
| Reasons for intervention | The reasons that led the treating physician to choose a surgical treatment will be collected from the files of the participants who were operated | within one month after operation | 
| operative finding and histologic results | The operative finding and histologic results will be collected from the files of the participants who were operated | within one month after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic mass, ovarian mass, ultrasound, serum markers, ovarian malignancy