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


N/A
N/A
N/A
Open (Enrolling)
Female
Ovarian Neoplasm

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Trial Information

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


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.


Inclusion Criteria:



- Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria:

- Pregnant women

- Known gynecologic malignancy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

The risk of malignancy in the presence of pelvic mass demonstrated by sonography.

Outcome Description:

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.

Outcome Time Frame:

Up to 2 months after recruiting and examining the last participant of the study

Safety Issue:

Yes

Principal Investigator

yfat kadan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Ob/Gyn, Haemek medical center, Afula Israel

Authority:

Israel: Ministry of Health

Study ID:

EMC-0083-09

NCT ID:

NCT01477788

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Ovarian Neoplasm
  • pelvic mass
  • ovarian mass
  • ultrasound
  • serum markers
  • ovarian malignancy
  • Neoplasms
  • Ovarian Neoplasms

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