Assessing ovarian cancer using ultrasound and laparoscopy
Validation of Doppler Ultrasound, CT Parameters Versus Laparoscopic Scoring in Assessment of Suspicious Ovarian Malignancy
This study is testing if using ultrasound and a minimally invasive procedure can help doctors better diagnose ovarian cancer in patients who show signs of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Mansoura, Dakahlia) |
| Trial ID | NCT06109545 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the use of ultrasound, including Doppler techniques, in diagnosing suspicious ovarian malignant tumors. It will also involve laparoscopic assessment of these findings, utilizing the Fagotti score to evaluate the malignancy of the tumors. Patients with clinical or radiological suspicion of ovarian cancer will be included, and their diagnostic results will be compared to determine the effectiveness of these imaging methods. The study focuses on patients with elevated CA125 levels and specific clinical presentations.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with clinical or radiological suspicion of ovarian cancer and elevated CA125 levels.
Not a fit: Patients with known malignancies at other sites or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing ovarian cancer, leading to earlier and more effective treatment options for patients.
How similar studies have performed: Other studies have explored similar diagnostic approaches, but the specific combination of ultrasound and laparoscopic assessment in this context may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. all patients with clinical or radiological suspicion of ovarian cancer. 2. at least one of clinical presentation of suspected or advanced ovarian cancer and performed ultrasound or CT or MRI that detect a pelvic mass and CA125 is more than 200 UL/ML. 3. patients with eastern Cooperative Oncology Group status from 0 to 3. Exclusion Criteria: 1. the women outside the age group in our study. 2. any known malignancy at other sites. 3. uncompliant patients who have severed uncontrolled infection or any other medical problem. 4. any previous major surgery. 5. patients who refuse to give an informed consent to do laparoscopy. 6. pregnancy and its complications.
Where this trial is running
Mansoura, Dakahlia
- Mansoura University Hospital — Mansoura, Dakahlia, Egypt (Recruiting)
Study contacts
- Principal investigator: Sarah Madany, MSc — Mansoura University
- Study coordinator: Sarah Madany, MSc
- Email: sarahmadany20@gmail.com
- Phone: +201027991297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.