SonographyNCT07289126
Sonographic Evaluation of Ovarian Masses by ORADS System
An observational study of Sonography and Ovarian Mass, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Sonography, Ovarian Mass
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- Any female patient with ovarian cyst or mass during routine trans-abdominal or pelvic US
- Age between 18 and 70 years.
Who cannot join
- 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 )
About this study
Official title: Sonographic Evaluation of Ovarian Masses by ORADS System in Woman's Health Hospital
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.
Read the 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.
- Conditions
- Sonography, Ovarian Mass
- Keywords
- ovarian masses, ORADS system, Ovarian-Adnexal Reporting and Data System Ultrasound, sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initial ultrasound examination to availability of final histopathology report for each participant (estimated up to 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SonographyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Emad Eldin Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289126
- Sponsor's protocol ID
- evaluation of ovarian masses
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of Ovarian Masses by ORADS System in Woman's Health Hospital
- ClinicalTrials.gov ID
- NCT07289126
- Acronym / sponsor ID
- evaluation of ovarian masses
- Conditions
- Sonography, Ovarian Mass
- Keywords
- ovarian masses, ORADS system, Ovarian-Adnexal Reporting and Data System Ultrasound, sonography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Any female patient with ovarian cyst or mass during routine trans-abdominal or pelvic US
- Age between 18 and 70 years.
Key exclusion criteria (5 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sonography and Ovarian Mass, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.