Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125 (CA125)

January 30, 2021 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)

The investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Beni-Suef University
        • Principal Investigator:
          • Nesreen A Shehata, Lecturer
        • Contact:
          • Abdelgany M Hassan, MD
          • Phone Number: 00201017801604
        • Sub-Investigator:
          • Abdelgany M Hassan, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for malignancy by RMI.

Description

Inclusion Criteria:

  • Women with complex ovarian cyst
  • Abdominal pain
  • Menometrorrhagia

Exclusion Criteria:

  • Significant weight loss
  • Cachexia
  • History of ovarian or other malignancy
  • Family history of ovarian Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
premenopausal women
premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125.
Other: Risk of malignancy index
Calculation of RMI before sugery.
Other Names:
  • RMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ovarian malignancy
Time Frame: one year
Calculation of number of women who had ovarian cancer after an operation in moderate risk
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Nesreen A Shehata, MD, Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Beni-Suef 6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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