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

NCT ID: NCT03193671

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

684 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2016-02-29

Brief Summary

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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

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 The patients were included before surgery and the biomarkers analysed on serum samples withdrawn preoperatively.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

Conditions

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Ovarian Neoplasms Diagnoses Disease Biomarkers Algorithms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Benign

Benign tumors, pre-and postmenopausal

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Improving diagnosis

Malignant

Malignant tumors, pre-and postmenopausal

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Improving diagnosis

Borderline

Borderline tumors, pre-and postmenopausal

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Improving diagnosis

Malignant+borderline

Malignant+borderline tumors, pre-and postmenopausal

Diagnosis

Intervention Type DIAGNOSTIC_TEST

Improving diagnosis

Interventions

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Diagnosis

Improving diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Karin Sundfeldt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gothenburg University, Sahlgrenska University Hospital

Gothenburg, Gothenburg, Sweden

Site Status

Countries

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Sweden

References

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Lycke M, Ulfenborg B, Malchau Lauesgaard J, Kristjansdottir B, Sundfeldt K. Consideration should be given to smoking, endometriosis, renal function (eGFR) and age when interpreting CA125 and HE4 in ovarian tumor diagnostics. Clin Chem Lab Med. 2021 Aug 13;59(12):1954-1962. doi: 10.1515/cclm-2021-0510. Print 2021 Nov 25.

Reference Type DERIVED
PMID: 34388324 (View on PubMed)

Other Identifiers

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Ksundfeldt

Identifier Type: -

Identifier Source: org_study_id

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