Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1700 participants
OBSERVATIONAL
2021-05-15
2028-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with an adnexal lesion in the Central Denmark Region
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
Regionshospitalet Horsens
OTHER
Department of Gynaecology and Obstetrics, Viborg Regional Hospital
UNKNOWN
Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital
UNKNOWN
Department of Gynaecology and Obstetrics, Randers Regional Hospital
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Ina Marie Dueholm Hjorth
Medical Doctor, PhD-student
Principal Investigators
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Ina Marie Dueholm Hjorth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Ole Mogensen, DMSci
Role: STUDY_DIRECTOR
University of Aarhus
Locations
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Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Ina Marie Dueholm Hjorth, MD
Role: primary
Other Identifiers
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adnexproject
Identifier Type: -
Identifier Source: org_study_id
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