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

NCT03193671CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Göteborg University

Enrollment

684

Start Date

2013-09-01

Completion Date

2016-02-29

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Diagnosis

Conditions

Ovarian NeoplasmsDiagnoses DiseaseBiomarkersAlgorithms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Improve triage of patients to tertiary centers for surgery

Referring the correct cases from a normal population.

Time frame: 12 months

Locations

Gothenburg University, Sahlgrenska University Hospital, Gothenburg, Sweden

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2021-08-13

Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics

Abstract Objectives To evaluate the impact of different biologic, histopathologic and lifestyle factors on serum levels of human epididymis protein 4 (HE4) and Cancer antigen 125 (CA125) in the diagnostic work up of women with an ovarian cyst or pelvic tumor. Methods The statistical evaluation was performed on a population of 445 women diagnosed with a benign ovarian disease, included in a large Swedish multicenter trial (ClinicalTrials.gov NCT03193671). Multivariable logistic regression analyses were performed to distinguish between the true negatives and false positives through adjusting for biologic, histopathologic and lifestyle factors on serum samples of CA125 and HE4 separately. The likelihood ratio test was used to determine statistical significance and Benjamini-Hochberg correction to adjust for multiple testing. Results A total of 31% of the women had false positive CA125 but only 9% had false positive results of HE4. Smoking (OR 6.62 95% CI 2.93–15.12) and impaired renal function, measured by eGFR (OR 0.18 95% CI 0.08–0.39), were independently predictive of falsely elevated serum levels of HE4. Endometriosis was the only variable predictive of falsely elevated serum levels of CA125 (OR 7.96 95% CI 4.53–14.39). Age correlated with increased serum levels of HE4. Conclusions Smoking, renal failure, age and endometriosis are factors that independently should be considered when assessing serum levels of HE4 and CA125 in women with an ovarian cyst or pelvic mass to avoid false indications of malignant disease.

Linked Investigators

Maria Lycke