Clinical trial · Observational
Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis
NCT03193671CI-TRIAL-00029333completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal population in the western region of Sweden. The aim is to improve diagnosis of ovarian cancer. If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Algorithms | — | UNRESOLVED | — |
| Biomarkers | — | UNRESOLVED | — |
| Diagnoses Disease | — | UNRESOLVED | — |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnosis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Benign
- description
- Benign tumors, pre-and postmenopausal
- interventionNames
- Diagnostic Test: Diagnosis
- label
- Malignant
- description
- Malignant tumors, pre-and postmenopausal
- interventionNames
- Diagnostic Test: Diagnosis
- label
- Borderline
- description
- Borderline tumors, pre-and postmenopausal
- interventionNames
- Diagnostic Test: Diagnosis
- label
- Malignant+borderline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age, understand spoken and written Swedish information, admitted for surgery for a cyst/tumos in the pelvis Exclusion Criteria: * Rejected participation, cytotoxic chemotherapy prior to surgery, rejected surgery, serum sample failure, already included at another hospital
References
Publications (1)
- DERIVEDLycke M, Ulfenborg B, Malchau Lauesgaard J, Kristjansdottir B, Sundfeldt K. Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics. Clin Chem Lab Med. 2021 Aug 13;59(12):1954-1962. doi: 10.1515/cclm-2021-0510. Print 2021 Nov 25. PMID 34388324