RECRUITINGOBSERVATIONAL

Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer

Evaluation of Prognostic and Predictive Values of Bespoke Circulating Tumor DNA Assay for Recurrent and Response Monitoring in Patients With Advanced Epithelial Ovarian Cancer

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

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

Locations (1)

Hao Wen

Shanghai, Shanghai Municipality, China