Sonographic Evaluation of Ovarian Masses by ORADS System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any female patient with ovarian cyst or mass during routine trans-abdominal or pelvic US
Age between 18 and 70 years.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Benign Ovarian Masses
Group B: Malignant Ovarian Masses
Trial outcomes
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.
Time frame
From initial ultrasound examination to availability of final histopathology report for each participant (estimated up to 3 months).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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