Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125

• Conditions: Ovarian Cancer
• Interventions: Other: Risk of malignancy index

• Registration Number: NCT02247323
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Study Start: 2016-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
premenopausal women	Risk of malignancy index	premenopausal women with complex ovarian mass moderate for malignancy by risk of malignancy index score and low CA125.

Primary Outcome Measures

Name	Time	Method
Incidence of ovarian malignancy	one year	Calculation of number of women who had ovarian cancer after an operation in moderate risk

Trial Locations

Locations (1)

Beni-Suef University; 🇪🇬 Cairo, Egypt