Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842629
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-03-08
Brief Title:
Improved Diagnosis of Ovarian Cancer
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Improved Diagnosis of Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None