Ovarian NeoplasmsNCT05842629
Improved Diagnosis of Ovarian Cancer
An observational study of Ovarian Neoplasms and Ovarian Cancer, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms, Ovarian Cancer, Ovarian Cysts
- How many people
- 1,700 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2021to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seen in hospitals in the Central Denmark Region during the project period.
Patients with an adnexal mass observed at ultrasonography.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus
Ina Marie Dueholm Hjorth, MD, +45 26192456
About this study
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.
Read the 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).
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Ovarian Cysts, Adnexal Mass, Adnexal Lesion, Adnexal Carcinoma
- Medical subject headings
- Ovarian Neoplasms, Ovarian Cysts, Carcinoma, Skin Appendage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an adnexal lesion in the Central Denmark Region | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficiency of available imaging modalities by models and subjective evaluation for pre-operative diagnosis of adnexal masses
Accuracy measures for diagnosis of ovarian cancer: Sensitivity, specificity, positive and negative predictive values.
Measured: 6 months
Area Under the Receiver Operating Characteristic Curve of ADNEX, O-RADS, two-step-strategy, Simple Rules and Risk of Malignancy Index.
Comparison of AUC's between models/strategies
Measured: 6 months
Secondary outcomes (3)
Longitudinal changes in adnexal masses
Change in imaging characteristics, occurrence of malignancy
Measured: Up to 5 years
Complications in women with conservatively managed adnexal masses
Incidence of torsion, rupture, spontaneous resolution, surgeries.
Measured: Up to 5 years
Observer variability
Inter- and intra observer variation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 May 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Horsens, Department of Gynaecology and Obstetrics, Viborg Regional Hospital, Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital, Randers Regional Hospital
- Responsible party
- Principal investigator, Ina Marie Dueholm Hjorth, Aarhus University Hospital
- Investigators
- Ina Marie Dueholm Hjorth, MD, Principal investigator, University of AarhusOle Mogensen, DMSci, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842629
- Sponsor's protocol ID
- adnexproject
- Status last verified
- May 2024
- First submitted
- 8 Mar 2023
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not currently planned.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnosis of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05842629
- Acronym / sponsor ID
- adnexproject
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Ovarian Cysts, Adnexal Mass, Adnexal Lesion, Adnexal Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Horsens, Department of Gynaecology and Obstetrics, Viborg Regional Hospital, Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital, Randers Regional Hospital
- Study start
- 15 May 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an adnexal lesion in the Central Denmark Region | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen in hospitals in the Central Denmark Region during the project period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic efficiency of available imaging modalities by models and subjective evaluation for pre-operative diagnosis of adnexal masses
Time frame: 6 months
Accuracy measures for diagnosis of ovarian cancer: Sensitivity, specificity, positive and negative predictive values.
Area Under the Receiver Operating Characteristic Curve of ADNEX, O-RADS, two-step-strategy, Simple Rules and Risk of Malignancy Index.
Time frame: 6 months
Comparison of AUC's between models/strategies
3 secondary outcomes
Longitudinal changes in adnexal masses
Time frame: Up to 5 years
Complications in women with conservatively managed adnexal masses
Time frame: Up to 5 years
Observer variability
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Not currently planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ina Marie Dueholm Hjorth, MD principal investigator
University of Aarhus
Ole Mogensen, DMSci study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Ovarian Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ina Marie Dueholm Hjorth, MD (+004526192456, imhjorth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficiency of available imaging modalities by models and subjective evaluation for pre-operative diagnosis of adnexal masses (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.