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NCT04188652
Diagnosing Ovarian Cysts - the DOC Study
trial testing Detailed symptomregistration in Ovarian Cysts in 1,123 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,123 |
| Start date | 1 January 2020 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Detailed symptomregistration
Conditions studied
- Ovarian Cysts — all drugs for Ovarian Cysts →
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Ovarian Neoplasms — all drugs for Ovarian Neoplasms →
- Ovarian Cancer Stage — all drugs for Ovarian Cancer Stage →
Sponsor
Rigshospitalet, Denmark
Who can join
18 and older, female only, with Ovarian Cysts or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Karlsen NS, Dreisler E, Høgdall CK, Høgdall ES, et al · · 2026 · PMID 42036775 · DOI 10.1111/1471-0528.70253
Verify or expand the search:
- PubMed search for NCT04188652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Currently open trials in the same condition.
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- NCT05763511 — Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker · recruiting
Other Rigshospitalet, Denmark trials
Trials by the same sponsor.
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- NCT07528729 — Alcohol as a Modifiable Risk Factor for Atrial Fibrillation · NA · not yet recruiting
- NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
- NCT07467187 — Invasive Home Ventilation in Denmark · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04188652 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 6 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04188652.
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