Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125

NCT ID: NCT02247323

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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premenopausal women

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

Risk of malignancy index

Intervention Type OTHER

Calculation of RMI before sugery.

Interventions

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Risk of malignancy index

Calculation of RMI before sugery.

Intervention Type OTHER

Other Intervention Names

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RMI

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Nesreen Abdel Fattah Abdullah Shehata

Assistant Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nesreen A Shehata, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

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Beni-Suef University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nesreen A Shehata, MD

Role: CONTACT

00201227866337

Abdelgany M Hassan, MD

Role: CONTACT

00201017801604

Facility Contacts

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Nesreen A Shehata, MD

Role: primary

00201227866337

Abdelgany M Hassan, MD

Role: backup

00201017801604

Related Links

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http://www.google.com.eg/search?q=National+Institute+for+health+and+clinical+excellence.+Ovarian+cancer%3AThe+recognition+and+initial+management+of+ovarian+cancer.NICE+clinical+guideline+122.London%3ANICE%3B2011&oq=National+In

National Institute for health and clinical excellence. Ovarian cancer:The recognition and initial management of ovarian cancer.NICE clinical guideline 122.London:NICE;2011

Other Identifiers

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Beni-Suef 6

Identifier Type: -

Identifier Source: org_study_id

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