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RECRUITING
NCT05763511

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

Sponsor: University of Aarhus

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2022-07-01

Completion Date

2029-05-04

Last Updated

2024-05-09

Healthy Volunteers

No

Locations (1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, Denmark