An observational study in Ovarian Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by Fudan University · Observational
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.
This observational study is designed for exploring prognostic and predictive values of the tumor-informed bespoke ctDNA assay in advanced EOC. Newly diagnosed patients who are eligible for radical surgery or relapsed patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery will be enrolled. The patients will be treated with SOC adjuvant therapies followed by PARP inhibitor for maintenance.
To evaluate ctDNA dynamics, tumor tissue collected from surgery will be sequenced with whole-exome sequencing (WES) to design patient-specific 16-plex panel. At planned monitoring timepoints, blood samples will be drawn, and ctDNA will be sequenced with ultra-deep ctDNA high-throughput sequencing methods.
Traditional surveillance methods will be applied as comparison, including but not limited to carbohydrate antigen 125 (CA-125)/ human epididymal protein 4 (HE4)/ carcinoembryonic antigen (CEA)/ carbohydrate antigen 199 (CA199), etc., as well as standard imaging.
Survival analyses will be conducted based on ctDNA status (positive/negative) after surgery. Recurrence rate of each subgroup, positive predictive values and negative predictive values etc. will be examined. Changes in ctDNA levels (ΔctDNA) during treatment will be used to evaluate the efficacy of maintenance therapy comparing traditional biomarkers,
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 139 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed advanced EOC patients who are eligible for radical surgery or relapsed EOC patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery.
Exclusion Criteria:
1. Newly diagnosed patients with advanced EOC (ND-EOC) who are eligible for radical surgery. 2. Patients relapsed from platinum-based therapy (rEOC) who are eligible for secondary cytoreductive surgery.
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
Progression free survival (PFS)
Determine PFS in ctDNA positive versus ctDNA negative groups.
Time frame: Two years
Overall Survival (OS)
Determine OS in ctDNA positive versus ctDNA negative groups.
Time frame: Two years
Plan to share: No
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