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

Göteborg University

Status: Completed

Conditions: Ovarian Neoplasms; Biomarkers; Diagnoses Disease; Algorithms

Treatments: Diagnostic Test: Diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT03193671

Ksundfeldt

Details and patient eligibility

About

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.

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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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

Enrollment: 684 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

684 participants in 4 patient groups

Benign

Description:

Benign tumors, pre-and postmenopausal

Treatment:

Diagnostic Test: Diagnosis

Malignant

Description:

Malignant tumors, pre-and postmenopausal

Treatment:

Diagnostic Test: Diagnosis

Borderline

Description:

Borderline tumors, pre-and postmenopausal

Treatment:

Diagnostic Test: Diagnosis

Malignant+borderline

Description:

Malignant+borderline tumors, pre-and postmenopausal

Treatment:

Diagnostic Test: Diagnosis