Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Neoplasms, Ovary Cancer, Ovarian Cysts. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Diagnostic efficiency (reference: histopathological diagnosis) [Time frame: 6 months]
Secondary outcome measures (5)
- Diagnostic efficiency of ctDNA combined with imaging (ultrasonography, MRI, PET-CT, CT, etc.) and CA 125 for differentiation of benign and malignant adnexal masses. [Time frame: 6 months]
- Disease stage [Time frame: 6 months]
- Treatment response [Time frame: 2 years]
- Survival [Time frame: 5 years]
- Tumour Biology [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Suspected ovarian neoplasm
- Informed consent
Exclusion criteria
- Inability to give informed consent
- Previous ovarian cancer diagnosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of Gynaecology and Obstetrics, Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT05763511 · Ovarian cancer ctDNA