NCT03193671

Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 684 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The investigators are currently using CA125 and RMI in diagnosing patients with a pelvic cyst/tumor and referring them to tertiary centers for surgery in the western region of Sweden. The diagnostic accuracy is unsatisfying why the investigators are evaluating HE4 and ROMA as a complement, in combination or separately to improve diagnostic accuracy. The trial is based on a normal population cohort of patients included at all the hospitals in the region. The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively. 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

• Ovarian Neoplasms
• Diagnoses Disease
• Biomarkers
• Algorithms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnosis	Improving diagnosis

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-02-29
• Completion: 2016-02-29
• First posted: 2017-06-21
• Last updated: 2017-08-29

Locations

1 site across 1 country: Sweden