NCT05763511 Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
| NCT ID | NCT05763511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Ovarian Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2024-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-07-01 with a primary completion date of 2024-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Suspected ovarian neoplasm * Informed consent Exclusion Criteria: * Inability to give informed consent * Previous ovarian cancer diagnosis
Contact & Investigator
Ina Marie Dueholm Hjorth, MD
PRINCIPAL INVESTIGATOR
University of Aarhus
Frequently Asked Questions
Who can join the NCT05763511 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05763511 currently recruiting?
Yes, NCT05763511 is actively recruiting participants. Contact the research team at imhjorth@gmail.com for enrollment information.
Where is the NCT05763511 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT05763511 clinical trial?
NCT05763511 is sponsored by University of Aarhus. The principal investigator is Ina Marie Dueholm Hjorth, MD at University of Aarhus. The trial plans to enroll 300 participants.