Ovarian Mass, Sonography
Conditions
Keywords
ovarian masses, ORADS system, Ovarian-Adnexal Reporting and Data System Ultrasound, sonography
Brief summary
This observational study will evaluate how well an ultrasound scoring system called O-RADS can distinguish between benign (non-cancerous) and malignant (cancerous) ovarian masses in women aged 18 to 70 years. Women who are found to have an ovarian cyst or mass during routine pelvic or transabdominal ultrasound at Women's Health Hospital will be invited to participate and will receive standard care, including detailed transvaginal ultrasound, MRI when indicated, surgery if needed, and histopathology (tissue examination). The main question is how accurately O-RADS ultrasound categories predict the final tissue diagnosis; the study will also look at how ultrasound findings relate to MRI results in characterizing ovarian masses.
Detailed description
This is a prospective cross-sectional diagnostic accuracy study designed to evaluate the performance of the Ovarian-Adnexal Reporting and Data System (O-RADS) ultrasound score in characterizing ovarian masses in women attending Woman's Health Hospital, Assiut University. The study addresses the challenge of differentiating benign from malignant adnexal lesions, a distinction that is essential for selecting appropriate management, avoiding unnecessary surgery, and optimizing referral to gynecologic oncology services. After obtaining informed consent, eligible women with an adnexal mass detected on routine gynecologic assessment undergo standardized clinical evaluation, laboratory testing as indicated, and dedicated pelvic ultrasound, preferably transvaginal. The ultrasound examination follows the O-RADS lexicon, documenting lesion morphology (e.g., size, internal architecture, presence of solid components or papillary projections, wall/septal features, echogenicity) and Doppler vascular characteristics, and assigning an O-RADS category (0-5) reflecting estimated malignancy risk. When clinically appropriate, pelvic MRI is performed to further assess lesion characteristics. Surgical management (laparoscopy or laparotomy) is undertaken according to routine care, and histopathologic evaluation of excised tissue serves as the reference standard.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Inclusion criteria
* Any female patient with ovarian cyst or mass during routine trans-abdominal or pelvic US * Age between 18 and 70 years.
Exclusion criteria
* Refusal of patients to filling consent. * Patient with a previous history of the operated ovarian lesion * Patient missed during follow-up or not provided pathology report. * Pregnancy. * Patients with functional ovarian masses ( e.g functional cysts )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of O-RADS ultrasound in differentiating benign from malignant ovarian masses | From initial ultrasound examination to availability of final histopathology report for each participant (estimated up to 3 months). | Proportion of correctly classified ovarian masses using the O-RADS ultrasound scoring system compared with the reference standard of postoperative histopathological diagnosis (benign vs malignant). Accuracy will be expressed as sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for O-RADS categories indicating malignancy. |
Outcome results
None listed