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

Beni-Suef University

Status: Unknown

Conditions: Ovarian Cancer

Treatments: Other: Risk of malignancy index

Study type: Observational

Funder types: Other

Identifiers

NCT02247323

Beni-Suef 6

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 45 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

premenopausal women

Description:

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

Treatment:

Other: Risk of malignancy index