Actively Recruiting
Improved Diagnosis of Ovarian Cancer Using Imaging and Biomarkers in Central Denmark Region
Led by University of Aarhus · Updated on 2024-05-09
1700
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adnexal masses, which are growths that occur near the ovaries, to improve how these masses are classified and whether they are benign or malignant. This observational study focuses on evaluating current imaging methods and biomarkers used by clinicians in the Central Denmark Region, aiming to enhance diagnosis and management. The study also looks at complications and changes over time in adnexal masses that are managed without surgery. Data is collected prospectively but analyzed retrospectively. Imaging techniques used in this study include ultrasonography, magnetic resonance imaging (MRI), and positron emission tomography-computed tomography (PET-CT). The diagnostic criteria follow guidelines from the International Ovarian Tumor Analysis (IOTA) group, and efforts are made to improve the quality of ultrasound descriptions through education on IOTA terminology. Patients receive diagnosis and treatment according to regional and national protocols. The study plans to include enough cases to detect differences in diagnostic sensitivity between various models and strategies. Participants will have their adnexal masses evaluated using imaging and biomarker models, and researchers will track diagnostic accuracy over six months. They will also monitor changes and complications in masses managed conservatively for up to five years. Observer variability in imaging interpretation is assessed as well. The study is conducted under ethical approval, with data collected during routine clinical care and analyzed to improve future diagnosis and management of adnexal masses.
CONDITIONS
Brief Title
Improved Diagnosis of Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with an adnexal mass observed at ultrasonography
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo imaging assessments including ultrasonography, MRI, and PET-CT to evaluate adnexal masses using established diagnostic models.
Multiple imaging visits within 6 months
Duration - Up to 5 years
Participants with adnexal masses are observed over time to monitor changes and any complications.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
Research Team
I
Ina Marie Dueholm Hjorth, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here