Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer
Recruiting now
Conditions studied: Ovarian Cancer
In brief
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.
Key facts
- Study ID
- NCT05446545
- Run by
- Fudan University
- People needed
- 139
- Starts
- 2021-09-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2023-12-28
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female, over 18 years of age;
- Patients with advanced epithelial ovarian cancer who are eligible for radical surgery;
- Patients with advanced epithelial ovarian cancer relapsed from platinum-based therapies and eligible for secondary cytoreductive surgery;
- The subjects agree to sign the informed consent and agree to use their samples and data for related scientific research;
- Subjects agree to collect tissue samples and peripheral blood samples for whole exon sequencing and ctDNA monitoring.
You may not qualify if…
- 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);
- Patients in pregnancy;
- Patients with a history of blood transfusion within 3 months before enrollment;
- Newly diagnosed patients who only received laparoscopic surgery;
- Patients received chemotherapy or other anti-tumor therapy before surgery.
Where it is running
- Hao Wen — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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