Actively Recruiting
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Led by University of Aarhus · Updated on 2024-05-09
300
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve the diagnosis of ovarian cancer in women who have suspected ovarian tumors. The study focuses on measuring circulating tumor DNA (ctDNA) to help distinguish between benign and malignant masses before surgery. Researchers also plan to explore how ctDNA relates to tumor type, stage, treatment response, and prognosis, aiming to develop a better diagnostic approach. Women participating in the study will have blood and tumor tissue samples collected, along with data from imaging tests such as ultrasonography, MRI, and PET-CT, as well as CA 125 blood tests. These samples and data will be gathered prospectively from patients referred to Aarhus University Hospital for suspected ovarian masses. Participants will be involved in various assessments including the analysis of ctDNA and imaging results to evaluate diagnostic accuracy compared to histopathological diagnosis. The study will also monitor disease stage, treatment response, survival rates, and tumor biology over time. The primary outcome will be measured within 6 months, with treatment response and survival tracked for up to 2 and 5 years respectively.
CONDITIONS
Brief Title
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected ovarian neoplasm
- Able to provide informed consent
- Female
- Age 18 years or older
You will not qualify if you...
- Unable to provide informed consent
- Previous diagnosis of ovarian cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo diagnostic procedures including blood tests for circulating tumor DNA and imaging scans to help differentiate ovarian masses.
Multiple visits depending on diagnostic procedures
Duration - Up to 5 years
Participants are monitored for treatment response, disease progression, and survival over time.
Periodic visits for assessments up to 5 years
Trial Site Locations
Total: 1 location
1
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
Research Team
I
Ina Marie Dueholm Hjorth, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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