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

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193671
• Other study ID #: Ksundfeldt
• 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
• 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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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

Related Conditions & MeSH terms

• Algorithms
• Biomarkers
• Diagnoses Disease
• Ovarian Cysts
• Ovarian Neoplasms

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