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Trial Title:
Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
NCT ID:
NCT05763511
Condition:
Ovarian Neoplasms
Ovary Cancer
Ovarian Cysts
Conditions: Official terms:
Ovarian Neoplasms
Ovarian Cysts
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients referred due to suspected ovarian cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Suspected ovarian neoplasm
- Informed consent
Exclusion Criteria:
- Inability to give informed consent
- Previous ovarian cancer diagnosis
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Address:
City:
Aarhus
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Ina Marie Dueholm Hjorth, MD
Phone:
+45 26192456
Start date:
July 1, 2022
Completion date:
May 4, 2029
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763511
