Diagnosing Ovarian Cysts - the DOC Study

Brief summary (registry, in English)

Background: Ovarian cysts are common in women. The vast majority is benign; yet, ovarian cancer (OC) is seen in 500 women every year in Denmark. OC is often diagnosed in advanced stages, and OC is the fifth most deadly cancer in women in more developed countries. It can be a clinical challenge to distinguish benign ovarian cysts from OC. Currently, the Risk of Malignancy Index (RMI) is used to detect women at high risk of OC in Denmark, however, new methods to correctly differentiate benign ovarian cysts from OC at an early stage is needed. New promising studies suggest an improved diagnostic accuracy by adding the biomarker Human Epididymis Protein 4 (HE4) and systemized ultrasound imaging International Ovarian Tumor Analysis (IOTA). Purpose: The purpose is to evaluate the diagnostic performance of HE4 and IOTA in a Danish clinical setting. Furthermore, to develop an optimized diagnostic algorithm to differentiate ovarian cysts based on a combination of symptoms, biomarkers and IOTA. Methods: The study is a prospective, observational study. Women with ovarian cysts are included from gynecological practitioners and departments in the Capital Region of Denmark. Detailed information on health and symptoms are registered, and the cysts are systematically described by the gynecologist in accordance to the IOTA terminology. HE4 will be analyzed in those women who routinely needs a diagnostic blood test for CA125. Data will be coupled with data from the patient file and Danish Gynecological Cancer Database (DGCD). The diagnostic utility of HE4 and IOTA will be evaluated both alone and in combinations with health information, symptoms, and CA125. The study has been approved by the Regional Committee on Health Research Ethics (H-19021342) and the Data Protection Agency (P-2019-340). Significance: This study establishes a unique database which will form the basis for developing an optimized method for differentiating ovarian cysts, and thus optimize referral and diagnosis.

What you commit to

• Study type: Observational
• Participants enrolled: 1123
• From 1 Jan 2020 to the primary completion date, 31 Dec 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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Related publications

• Evaluation of the IOTA ADNEX Model, Two-Step Strategy and RMI in Routine Gynaecologic Care in Denmark and Implications for Implementation: A Prospective Multicenter Cohort Study.BJOG · 2026 · PMID 42036775