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NCT Number: NCT05842629

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.

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Key information

Conditions

Ovarian Neoplasms Adenocarcinoma Adnexal Carcinoma Adnexal Diseases Adnexal Lesion Adnexal Mass Adnexal Neoplasm Carcinoma Carcinoma, Skin Appendage Cysts Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Adnexal and Skin Appendage Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Cysts Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, Denmark

Location status: Recruiting

Location contact

Ina Marie Dueholm Hjorth, MD

CONTACT

+45 26192456

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients with an adnexal mass observed at ultrasonography.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Longitudinal changes in adnexal masses

    Time frame: Up to 5 years

    Change in imaging characteristics, occurrence of malignancy

  2. Complications in women with conservatively managed adnexal masses

    Time frame: Up to 5 years

    Incidence of torsion, rupture, spontaneous resolution, surgeries.

  3. Observer variability

    Time frame: 6 months

    Inter- and intra observer variation

Study contacts

Contact information is provided by the study sponsor or research team.

Ina Marie Dueholm Hjorth, MD

CONTACT

[email protected]

+004526192456

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital
  • Department of Gynaecology and Obstetrics, Viborg Regional Hospital
  • Randers Regional Hospital
  • Regionshospitalet Horsens

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
May 6, 2023
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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