Personalized blood test for monitoring ovarian cancer treatment and recurrence
Evaluation of Prognostic and Predictive Values of Bespoke Circulating Tumor DNA Assay for Recurrent and Response Monitoring in Patients With Advanced Epithelial Ovarian Cancer
This study is testing a personalized blood test to see if tracking cancer DNA can help doctors better monitor treatment and recurrence in women with advanced ovarian cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 139 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05446545 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer undergoing surgery and subsequent treatments. Patients will be monitored using a bespoke ctDNA assay alongside traditional surveillance methods like CA125 and imaging. The study will involve sequencing tumor tissue to create a patient-specific ctDNA panel and analyzing blood samples at various timepoints to assess treatment response and recurrence. The goal is to gather preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.
Who should consider this trial
Good fit: Ideal candidates include women over 18 with advanced epithelial ovarian cancer eligible for radical surgery or those relapsed from platinum-based therapies eligible for secondary surgery.
Not a fit: Patients with other active cancers, those who are pregnant, or those who have received prior chemotherapy before surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective monitoring of treatment responses and recurrence in ovarian cancer patients.
How similar studies have performed: While the use of ctDNA monitoring is gaining traction, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Hao Wen — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hao Wen, MD
- Email: wenhao@shca.org.cn
- Phone: +86-021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.