Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ND-EOC or platinum-sensitive rEOC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ND-EOC or platinum-sensitive rEOC
- description
- 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.
- interventionNames
- Other: ND-EOC or platinum-sensitive rEOC
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- Two years
- description
- Determine PFS in ctDNA positive versus ctDNA negative groups.
Secondary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Two years
- description
- Determine OS in ctDNA positive versus ctDNA negative groups.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available