Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker

NCT05763511RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

300

Start Date

2022-07-01

Completion Date

2024-12-04

Study Type

OBSERVATIONAL

Official Title

Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker

Conditions

Ovarian NeoplasmsOvary CancerOvarian Cysts

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Suspected ovarian neoplasm
* Informed consent

Exclusion Criteria:

* Inability to give informed consent
* Previous ovarian cancer diagnosis

Outcome Measures

Primary Outcomes

Diagnostic efficiency (reference: histopathological diagnosis)

Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.

Time frame: 6 months

Secondary Outcomes

Diagnostic efficiency of ctDNA combined with imaging (ultrasonography, MRI, PET-CT, CT, etc.) and CA 125 for differentiation of benign and malignant adnexal masses.

Area under the receiver operation characteristic curve, sensitivity, specificity, positive and negative predictive values.

Time frame: 6 months

Disease stage

FIGO stage

Time frame: 6 months

Treatment response

Response to treatment

Time frame: 2 years

Survival

Survival rate

Time frame: 5 years

Tumour Biology

Mutational profile assessed by Whole Exome Sequencing.

Time frame: 6 months

Locations

Department of Gynaecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark