Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

This study has been withdrawn prior to enrollment.
(The researcher Left the organization)
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01477788
First received: November 13, 2011
Last updated: June 17, 2015
Last verified: November 2011

November 13, 2011
June 17, 2015
May 2011
May 2011   (final data collection date for primary outcome measure)
The risk of malignancy in the presence of pelvic mass demonstrated by sonography. [ Time Frame: Up to 2 months after recruiting and examining the last participant of the study ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01477788 on ClinicalTrials.gov Archive Site
  • number and kind of operative complications [ Time Frame: within one month after operation ] [ Designated as safety issue: Yes ]
    Information about operative complications will be collected from the files of participants who were operated
  • Reasons for intervention [ Time Frame: within one month after operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: within one month after operation ] [ Designated as safety issue: No ]
    The operative finding and histologic results will be collected from the files of the participants who were operated
Same as current
Not Provided
Not Provided
 
Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass
Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients referred to the department's sonographic unit with diagnosis of adnexal or pelvic or ovarian mass
Ovarian Neoplasm
Not Provided
women, sonographic ovarian mass
women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria:

  • Pregnant women
  • Known gynecologic malignancy
Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01477788
EMC-0083-09
No
Not Provided
Not Provided
HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Women and Infants Hospital of Rhode Island
Principal Investigator: yfat kadan, MD Department of Ob/Gyn, Haemek medical center, Afula Israel
HaEmek Medical Center, Israel
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP