ND-EOC or platinum-sensitive rEOC: platinum-based combined chemotherapy or bevacizumab will be used for adjuvant treatment, followed by maintenance therapy with poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, or bevacizumab, or other anti-tumor angiogenesis drugs or immune checkpoint inhibitors
Study summary
This prospective observational study is to assess the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer (EOC) undergoing surgery, adjuvant chemotherapy, followed by poly adenosine diphosphate-ribose polymerase (PARP) inhibitors until disease progression or the end of the study. All patients will be closely monitored throughout the course of disease by a tumor-informed bespoke ctDNA assay as well as traditional methods of surveillance, such as CA125 and imaging. This study may provide preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Female, over 18 years of age;
2. Patients with advanced epithelial ovarian cancer who are eligible for radical surgery;
3. Patients with advanced epithelial ovarian cancer relapsed from platinum-based therapies and eligible for secondary cytoreductive surgery;
4. The subjects agree to sign the informed consent and agree to use their samples and data for related scientific research;
5. Subjects agree to collect tissue samples and peripheral blood samples for whole exon sequencing and ctDNA monitoring.
Exclusion Criteria:
1. Patients who are diagnosed, tested or treated for cancer other than ovarian cancer within 2 years (except for basal skin or squamous cell cancer that has been definitively treated);
2. Patients in pregnancy;
3. Patients with a history of blood transfusion within 3 months before enrollment;
4. Newly diagnosed patients who only received laparoscopic surgery;
5. Patients received chemotherapy or other anti-tumor therapy before surgery.
Primary outcome measure(s)
Progression free survival (PFS) — Two years Determine PFS in ctDNA positive versus ctDNA negative groups.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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