To hear about similar clinical trials, please enter your email below

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
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

Login to your account

Did you forget your password?