Diagnosing Ovarian Cysts - the DOC Study

NCT04188652CompletedOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

Rigshospitalet, Denmark

Enrollment

1123

Start Date

2020-01-01

Completion Date

2024-12-31

Study Type

OBSERVATIONAL

Official Title

Diagnosing Ovarian Cysts - the DOC Study

Interventions

Detailed symptomregistration

Conditions

Ovarian CystsOvarian CancerOvarian NeoplasmsOvarian Cancer Stage

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* women diagnosed with ovarian cysts
* age 18 or above
* understanding, speaking, and writing Danish

Exclusion Criteria:

* age \< 18
* unable to provide consent

Outcome Measures

Primary Outcomes

Number of women with benign ovarian disease, borderline ovarian tumors, and ovarian cancer

Histology of ovarian cysts

Time frame: Assessed regularly through study inclusion period in a total period of 2,5-3 years

FIGO stage of ovarian cancer

FIGO stage of ovarian cancer

Time frame: Assessed regularly through study inclusion period in a total period of 2,5-3 years

Diagnostic utility of HE4, CPH-I and IOTA in differentiating ovarian cysts

The diagnostic accuracy (SN, SP, PPV, NPV, AUC) of HE4, CPH-I, and IOTA to determinie ability to differentiate healthy women, women with non-gynecologic disease, benign gynecologic disease, borderline ovarian tumors, and OC will be examined using univariate and multivariate logistic regression analyses. Diagnostic utility of HE4, CPH-I and IOTA will be compared to CA125, ROMA and RMI.

Time frame: Assesed after study inclusion and data collection after 3 years.

Locations

Claus Kim Høgdall, Copenhagen, Denmark

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Diagnosing Ovarian Cysts - the DOC Study