Sonographic Evaluation of Ovarian Masses by ORADS System

NCT07289126 | Not Yet Recruiting

• 1 other identifier: evaluation of ovarian masses
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sonography; Ovarian Mass

Keywords

ovarian masses; ORADS system; Ovarian-Adnexal Reporting and Data System Ultrasound; sonography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of O-RADS ultrasound in differentiating benign from malignant ovarian masses

  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.

  From initial ultrasound examination to availability of final histopathology report for each participant (estimated up to 3 months).

Study Arms (2)

Benign Ovarian Masses

Women aged 18-70 years with ovarian cysts or masses detected on transabdominal or transvaginal ultrasound, whose lesions are finally confirmed as benign by histopathology after standard clinical management, including ultrasound evaluation by O-RADS, MRI (when indicated), and surgical exploration or follow-up.

Malignant Ovarian Masses

Women aged 18-70 years with ovarian cysts or masses detected on transabdominal or transvaginal ultrasound, whose lesions are finally confirmed as malignant by histopathology after standard clinical management, including ultrasound evaluation by O-RADS, MRI (when indicated), and surgical exploration.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 70 years attending the Women's Health Hospital, Assiut University, with ovarian cysts or masses detected on routine transabdominal or transvaginal ultrasound will be invited to participate. Eligible patients will undergo standardized clinical assessment, ultrasound evaluation using the O-RADS system, MRI when clinically indicated, and subsequent surgical exploration and histopathological examination or follow-up according to usual care. Patients with prior ovarian surgery for the same lesion, pregnancy, functional ovarian cysts, or those who decline consent or are lost before histopathological confirmation will be excluded.

You may qualify if:

• Any female patient with ovarian cyst or mass during routine trans-abdominal or pelvic US
• Age between 18 and 70 years.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Obstetrics and Gynecology Department, Assiut University

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12