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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01477788
Other study ID # EMC-0083-09
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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