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

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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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

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

Conditions
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Ovarian Neoplasms, Diagnoses Disease, Biomarkers, Algorithms

Intervention / Treatment
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* Diagnostic Test: Diagnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Benign<br>Benign tumors, pre-and postmenopausal | Diagnostic Test: Diagnosis<br>* Improving diagnosis<br>|
| Malignant<br>Malignant tumors, pre-and postmenopausal | Diagnostic Test: Diagnosis<br>* Improving diagnosis<br>|
| Borderline<br>Borderline tumors, pre-and postmenopausal | Diagnostic Test: Diagnosis<br>* Improving diagnosis<br>|
| Malignant+borderline<br>Malignant+borderline tumors, pre-and postmenopausal | Diagnostic Test: Diagnosis<br>* Improving diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can the investigators improve diagnostic accuracy in women diagnosed with a cyst/tumor in the pelvis | Finding the true cases and avoiding unnecessary surgery, a descriptive analysis of a normalpopulation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve triage of patients to tertiary centers for surgery | Referring the correct cases from a normal population. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HE4, CA125, RMI, ROMA