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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hao Wen
RECRUITING
Shanghai
Contact Information
Primary
Hao Wen, MD
wenhao@shca.org.cn
+86-021-64175590
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 139
Treatments
ND-EOC or platinum-sensitive rEOC
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.
Related Therapeutic Areas
Sponsors
Collaborators: BGI Tianjin
Leads: Fudan University

This content was sourced from clinicaltrials.gov