Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

Withdrawn

• Conditions: Ovarian Neoplasm

• Registration Number: NCT01477788
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-11
• Study First Submitted: 2011-11-13
• Study First Submitted QC: 2011-11-19
• Study First Posted: 2011-11-23
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria

• Pregnant women
• Known gynecologic malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The risk of malignancy in the presence of pelvic mass demonstrated by sonography.	Up to 2 months after recruiting and examining the last participant of the study	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.

Secondary Outcome Measures

Name	Time	Method
number and kind of operative complications	within one month after operation	Information about operative complications will be collected from the files of participants who were operated
Reasons for intervention	within one month after operation	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	within one month after operation	The operative finding and histologic results will be collected from the files of the participants who were operated

Trial Locations

Locations (1)

Sonographic unit, Department of Ob/Gyn, Haemek medical center; 🇮🇱 Afula, Israel