Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

NCT ID: NCT01477788

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Ovarian Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

women, sonographic ovarian mass

women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria

• Pregnant women
• Known gynecologic malignancy

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yfat kadan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Sonographic unit, Department of Ob/Gyn, Haemek medical center

Afula, , Israel

Countries

Israel

Other Identifiers

EMC-0083-09

Identifier Type: -

Identifier Source: org_study_id