Improved Diagnosis of Ovarian Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cysts; Ovarian Neoplasms; Ovarian Cancer; Adnexal Mass; Adnexal Lesion; Adnexal Carcinoma; Adnexal Neoplasm

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 Type: Observational
• Enrollment (Anticipated): 1700

Contacts and Locations

• Study Contact: Name: Ina Marie Dueholm Hjorth, MD; Phone Number: +004526192456; Email: imhjorth@gmail.com

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Department of Gynaecology and Obstetrics, Aarhus University Hospital
    • Contact: Ina Marie Dueholm Hjorth, MD; Phone Number: +45 26192456

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients seen in hospitals in the Central Denmark Region during the project period.

Description

Patients with an adnexal mass observed at ultrasonography.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with an adnexal lesion in the Central Denmark Region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal changes in adnexal masses	Change in imaging characteristics, occurrence of malignancy	Up to 5 years
Complications in women with conservatively managed adnexal masses	Incidence of torsion, rupture, spontaneous resolution, surgeries.	Up to 5 years
Observer variability	Inter- and intra observer variation	6 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Department of Clinical Medicine, Aarhus University; Department of Gynaecology and Obstetrics, Aarhus University Hospital; Department of Gynaecology and Obstetrics, Horsens Regional Hospital; Department of Gynaecology and Obstetrics, Viborg Regional Hospital; Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital; Department of Gynaecology and Obstetrics, Randers Regional Hospital
• Investigators: Principal Investigator: Ina Marie Dueholm Hjorth, MD, University of Aarhus; Study Director: Ole Mogensen, DMSci, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Neoplasms, Adnexal and Skin Appendage; Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Ovarian Cysts; Carcinoma, Skin Appendage
• Other Study ID Numbers: adnexproject

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not currently planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No