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NCT Number: NCT07289126

Sonographic Evaluation of Ovarian Masses by ORADS System

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Sonographic Evaluation of Ovarian Masses by ORADS System in Woman's Health Hospital

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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