Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

Ovarian Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01477788
• Other study ID #: EMC-0083-09
• Status: Withdrawn
• Phase: N/A
• First received: November 13, 2011
• Last updated: June 17, 2015
• Start date: May 2011
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria:

• Pregnant women

• Known gynecologic malignancy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ovarian Neoplasm
• Ovarian Neoplasms

Locations

Country	Name	City	State
Israel	Sonographic unit, Department of Ob/Gyn, Haemek medical center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	Yes
Secondary	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	No
Secondary	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	No