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Trial Title:
Ovarian Malignancy Incidence in Moderate Risk Women With Low CA 125
NCT ID:
NCT02247323
Condition:
Ovarian Cancer
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Risk of malignancy index
Description:
Calculation of RMI before sugery.
Arm group label:
premenopausal women
Other name:
RMI
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
Criteria for eligibility:
Study pop:
Premenopausal who had complex ovarian mass with low CA125 and at moderate risk for
malignancy by RMI.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
45 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beni-Suef University
Address:
City:
Cairo
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nesreen A Shehata, MD
Phone:
00201227866337
Email:
nesoomar@yahoo.com
Contact backup:
Last name:
Abdelgany M Hassan, MD
Phone:
00201017801604
Investigator:
Last name:
Nesreen A Shehata, Lecturer
Email:
Principal Investigator
Investigator:
Last name:
Abdelgany M Hassan, Lecturer
Email:
Sub-Investigator
Start date:
January 2016
Completion date:
December 2021
Lead sponsor:
Agency:
Beni-Suef University
Agency class:
Other
Source:
Beni-Suef University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02247323
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