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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03193671

Enrollment

684

Registered

2017-06-21

Start date

2013-09-01

Completion date

2016-02-29

Last updated

2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Algorithms, Biomarkers, Diagnoses Disease, Ovarian Neoplasms

Keywords

HE4, CA125, RMI, ROMA

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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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

Interventions

DIAGNOSTIC_TESTDiagnosis

Improving diagnosis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026