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Trial Title:
Improved Diagnosis of Ovarian Cancer
NCT ID:
NCT05842629
Condition:
Ovarian Neoplasms
Ovarian Cancer
Ovarian Cysts
Adnexal Mass
Adnexal Lesion
Adnexal Carcinoma
Adnexal Neoplasm
Conditions: Official terms:
Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ovarian Cysts
Carcinoma, Skin Appendage
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
After implementation of systematic image description of adnexal masses, we aim to improve
and evaluate our use of available imaging methods and biomarkers for classifying adnexal
masses and distinguishing between benign and malignant adnexal masses in the hands of
clinicians in Central Denmark Region.
Secondarily, we want to improve our management of adnexal masses by evaluating the
complications and longitudinal changes in conservatively managed adnexal masses.
Data is registered prospectively but analyzed retrospectively.
Detailed description:
Imaging methods include ultrasonography (US) by varied observers, Magnetic Resonance
Imaging (MRI) and Positron Emission Tomography-Computed Tomography (PET-CT).
Imaging criteria are based on recommendations by the International Ovarian Tumor Analysis
(IOTA) group. Educational efforts in IOTA terminology and systematic description at
ultrasonography may support quality in the diagnostic process.
Patients will be diagnosed and treated according to national and regional guidelines by
the local clinicians.
The project has been evaluated by the Ethical Committee in the Central Denmark Region
prior to initiation.
The aim of the power calculation for estimation of sample size is to be able to detect a
difference in sensitivity from 75% to 90% at a threshold of 200 for Risk of Malignancy
Index (RMI) and 10% for Assessment of Different NEoplasia of the adneXa (ADNEX) model and
two-step-strategy / The Ovarian-Adnexal Reporting and Data System (O-RADS). To detect a
difference in sensitivity (90% for ADNEX and two-step-strategy vs 75% for RMI at a
specificity of 80%) at least 103 cases of malignancy should be included (calculated by
using paired proportions).
Criteria for eligibility:
Study pop:
Patients seen in hospitals in the Central Denmark Region during the project period.
Sampling method:
Probability Sample
Criteria:
Patients with an adnexal mass observed at ultrasonography.
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Address:
City:
Aarhus
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Ina Marie Dueholm Hjorth, MD
Phone:
+45 26192456
Start date:
May 15, 2021
Completion date:
December 2028
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Department of Gynaecology and Obstetrics, Horsens Regional Hospital
Agency class:
Other
Collaborator:
Agency:
Department of Gynaecology and Obstetrics, Viborg Regional Hospital
Agency class:
Other
Collaborator:
Agency:
Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital
Agency class:
Other
Collaborator:
Agency:
Department of Gynaecology and Obstetrics, Randers Regional Hospital
Agency class:
Other
Collaborator:
Agency:
Department of Clinical Medicine, Aarhus University
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842629
