Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Aarhus
About this trial
This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy.
We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses.
Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm.
The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored.
Analyses of blood and tissue samples will be used to examine the disease development and biology.
Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected ovarian neoplasm
Informed consent
Disqualifiers
Inability to give informed consent
Previous ovarian cancer diagnosis
Trial population
Patients referred due to suspected ovarian cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Diagnostic efficiency (reference: histopathological diagnosis)
Sensitivity, Specificity, Area under the receiver operation characteristic curve, positive and negative predictive values.
Time frame
6 monthsSecondary outcomes
1
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 months2
Disease stage
FIGO stage
Time frame
6 months3
Treatment response
Response to treatment
Time frame
2 years4
Survival
Survival rate
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov