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Clinical Trials in China / NCT05446545
Recruiting Observational

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

NCT05446545 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Observational
Started
2021-09-01
Last updated
2023-12-28

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

ND-EOC or platinum-sensitive rEOC

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)

Trial sites (1)

FacilityCityRegionStatus
Hao Wen Shanghai Shanghai Municipality Recruiting

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Official registry record

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.

View NCT05446545 on ClinicalTrials.gov ↗ ← All trials in China