Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
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: November 19, 2011
Last verified: November 2011
  Purpose

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).


Condition
Ovarian Neoplasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prediction of Ovarian Malignancy, in the Presence of Sonographic Pelvic Mass Using Patient History, Sonographic Parameters and Serum Markers

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 800
Study Start Date: May 2011
Groups/Cohorts
women, sonographic ovarian mass
women that will arrive to the sonographic unit of the gynecological department with the sonographic diagnosis of ovarian mass

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to the department's sonographic unit with diagnosis of adnexal or pelvic or ovarian mass

Criteria

Inclusion Criteria:

  • Patients referred with sonographic diagnosis of pelvic mass

Exclusion Criteria:

  • Pregnant women
  • Known gynecologic malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477788

Contacts
Contact: yfat kadan, MD 972506943426 yfat.kadan@gmail.com
Contact: abeer suleiman, MD 972503441700 abeer_su@clalit.org.il

Locations
Israel
Sonographic unit, Department of Ob/Gyn, Haemek medical center Recruiting
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: yfat kadan, MD Department of Ob/Gyn, Haemek medical center, Afula Israel
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01477788     History of Changes
Other Study ID Numbers: EMC-0083-09
Study First Received: November 13, 2011
Last Updated: November 19, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
pelvic mass
ovarian mass
ultrasound
serum markers
ovarian malignancy

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on October 01, 2014