Using ctDNA to Measure Treatment Effectiveness in Ovarian Cancer
Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
This study is testing if measuring tumor DNA in the blood can help predict how well treatment works for people with high-grade serous ovarian cancer who are on maintenance therapy after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05027828 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial focuses on patients diagnosed with high-grade serous ovarian cancer who are receiving first-line maintenance treatment with PARP inhibitors following chemotherapy. The study involves collecting plasma samples at various stages, including before surgery, after chemotherapy, during maintenance therapy, and at disease progression, to analyze circulating tumor DNA (ctDNA) for specific genomic markers. The goal is to determine if ctDNA can predict the effectiveness of the treatment and facilitate early detection of disease recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed high-grade serous ovarian cancer who are eligible for surgical treatment.
Not a fit: Patients with non-epithelial ovarian cancer or those who cannot undergo surgical treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for predicting treatment efficacy and early recurrence in ovarian cancer patients.
How similar studies have performed: While the use of ctDNA as a biomarker is gaining traction, this specific approach in ovarian cancer treatment is still being explored and may represent a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ovarian cancer first diagnosed and treated; 2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; 3. The stage of the disease is II-IV, and surgery will be performed after evaluation; 4. Age ≥ 18 years old; 5. Subjects and their families fully understand the research plan and sign an informed consent form. Exclusion Criteria: 1. Pathologically confirmed as non-epithelial ovarian cancer; 2. Surgical treatment cannot be performed after evaluation; 3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment; 4. Patients who do not agree to use clinical first-line targeted drugs; 5. Severe mental illness; 6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.
Where this trial is running
Shanghai
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, China (Recruiting)
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.