Improved Diagnosis of Ovarian Cancer

NCT05842629 | Recruiting

• 1 other identifier: adnexproject
• Study Type: observational
• Target: 1,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms; Ovarian Cancer; Ovarian Cysts; Adnexal Mass; Adnexal Lesion; Adnexal Carcinoma; Adnexal Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Longitudinal changes in adnexal masses

  Up to 5 years

• Complications in women with conservatively managed adnexal masses

  Up to 5 years

• Observer variability

  6 months

Study Arms (1)

Patients with an adnexal lesion in the Central Denmark Region

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

Patients with an adnexal mass observed at ultrasonography.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, Denmark

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Ovarian Cysts; Carcinoma, Skin Appendage

Condition Hierarchy (Ancestors)

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

Study Officials

• Ina Marie Dueholm Hjorth, MD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Ole Mogensen, DMSci

  University of Aarhus

  STUDY DIRECTOR

Central Study Contacts

Ina Marie Dueholm Hjorth, MD

CONTACT

+004526192456; imhjorth@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD-student

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: May 6, 2023
• Study Start: May 15, 2021
• Primary Completion: June 1, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)