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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03193671
Other study ID # Ksundfeldt
Secondary ID
Status Completed
Phase N/A
First received June 19, 2017
Last updated August 28, 2017
Start date September 1, 2013
Est. completion date February 29, 2016

Study information

Verified date August 2017
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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


Recruitment information / eligibility

Status Completed
Enrollment 684
Est. completion date February 29, 2016
Est. primary completion date February 29, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Diagnosis
Improving diagnosis

Locations

Country Name City State
Sweden Gothenburg University, Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

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