Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Recruiting now
Conditions studied: Ovarian Neoplasms, Ovary Cancer, Ovarian Cysts
In brief
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 facts
- Study ID
- NCT05763511
- Run by
- University of Aarhus
- People needed
- 300
- Starts
- 2022-07-01
- Expected to finish
- 2029-05-04
- Last updated by the study team
- 2024-05-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Suspected ovarian neoplasm
- Informed consent
You may not qualify if…
- Inability to give informed consent
- Previous ovarian cancer diagnosis
Where it is running
- Department of Gynaecology and Obstetrics, Aarhus University Hospital — Aarhus, Denmark (enrolling)
Full record on ClinicalTrials.gov
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