RecruitingNCT05763511

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


Sponsor

University of Aarhus

Enrollment

300 participants

Start Date

Jul 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a blood test that detects fragments of tumor DNA (called circulating tumor DNA, or ctDNA) can help doctors more accurately diagnose ovarian cancer before or during evaluation. This kind of liquid biopsy may offer a less invasive way to detect cancer. **You may be eligible if...** - You are being evaluated for a suspected ovarian growth or tumor - You are willing and able to give informed consent **You may NOT be eligible if...** - You are unable to give informed consent - You have previously been diagnosed with ovarian cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, Denmark

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NCT05763511


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