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

Completed

• Conditions: Ovarian Neoplasms; Diagnoses Disease; Biomarkers; Algorithms
• Interventions: Diagnostic Test: Diagnosis

• Registration Number: NCT03193671
• Lead Sponsor: Göteborg University

Brief 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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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.

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2016-02-29
• Study Completion: 2016-02-29
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 684

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malignant	Diagnosis	Malignant tumors, pre-and postmenopausal
Borderline	Diagnosis	Borderline tumors, pre-and postmenopausal
Malignant+borderline	Diagnosis	Malignant+borderline tumors, pre-and postmenopausal
Benign	Diagnosis	Benign tumors, pre-and postmenopausal

Primary Outcome Measures

Name	Time	Method
Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis	12 months	Finding the true cases and avoiding unnecessary surgery, a descriptive analysis of a normalpopulation

Secondary Outcome Measures

Name	Time	Method
Improve triage of patients to tertiary centers for surgery	12 months	Referring the correct cases from a normal population.

Trial Locations

Locations (1)

Gothenburg University, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden