iquid biopsies for improving the pre-operative diagnosis of ovarian cancer
Recruiting
- Conditions
- cancer of the ovaryovarian cancer1003859410029903
- Registration Number
- NL-OMON51106
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
1. Age >=18 years
2. Presence of a ovarian tumor and referred to specialized center for surgery
based on:
a. Any ultrasound model
b. Subjective assessment of the referring gynecologist
c. Normal Glomerular Filtration Rate (GFR): >60ml/min/1,73m2
3.General criteria:
a. Understanding of Dutch language
b. Fit for surgery (WHO 1-2)
c. Written informed consent
Exclusion Criteria
1. Suspicion of advanced-stage of disease, e.g. ascites or peritoneal
depositions
2. History of cancer (excl. BCC) within 5 years prior to inclusion
3. Multiple malignancies at the same time
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The sensitivity and specificity of a new diagnostic algorithm including liquid<br /><br>biopsies, to differentiate patients with ovarian cancer from patients with a<br /><br>benign ovarian tumor. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Calculation of cost-effectiveness of addition of plasma liquid biopsy<br /><br>measurement in the triage of patients with an ovarian tumor.<br /><br>2. Psychological burden of the uncertainty of having cancer or not before<br /><br>surgical treatment. </p><br>