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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02247323
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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

Condition or disease Intervention/treatment
Ovarian Cancer Other: Risk of malignancy index

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: RMI

Primary Outcome Measures :
  1. Incidence of ovarian malignancy [ Time Frame: one year ]
    Calculation of number of women who had ovarian cancer after an operation in moderate risk

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for malignancy by RMI.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02247323

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Contact: Nesreen A Shehata, MD 00201227866337
Contact: Abdelgany M Hassan, MD 00201017801604

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Beni-Suef University Recruiting
Cairo, Egypt
Contact: Nesreen A Shehata, MD    00201227866337   
Contact: Abdelgany M Hassan, MD    00201017801604      
Principal Investigator: Nesreen A Shehata, Lecturer         
Sub-Investigator: Abdelgany M Hassan, Lecturer         
Sponsors and Collaborators
Beni-Suef University
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Principal Investigator: Nesreen A Shehata, MD Beni-Suef University

Additional Information:
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Responsible Party: Nesreen Abdel Fattah Abdullah Shehata, Assistant Professor of Obstetrics and Gynecology, Beni-Suef University Identifier: NCT02247323     History of Changes
Other Study ID Numbers: Beni-Suef 6
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018