Actively Recruiting
Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-24
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective observational trial involving patients newly diagnosed and treated for high-grade serous ovarian cancer. The study aims to evaluate circulating tumor DNA (ctDNA) as a novel molecular marker to predict the effectiveness of PARP inhibitors and to detect early disease recurrence. This research is led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Participants will receive first-line maintenance treatment with PARP inhibitors following traditional chemotherapy. The study collects plasma samples at multiple points: before surgery, after chemotherapy, during targeted maintenance therapy, and if disease progresses. These samples are analyzed for ctDNA-specific genomes alongside clinical data to assess treatment response. During the trial, participants will undergo regular plasma collection and clinical evaluations. Researchers will monitor progression-free survival approximately 36 months after starting PARP inhibitors, with secondary measures including overall survival over 5 years and objective response rates at 36 months. This thorough monitoring helps track treatment effects and disease status over time.
CONDITIONS
Brief Title
CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ovarian cancer first diagnosed and treated
- Pathological confirmation of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Disease stage II to IV with planned surgery after evaluation
- Age 18 years or older
- Informed consent signed by participant and family who fully understand the study plan
You will not qualify if you...
- Non-epithelial ovarian cancer confirmed pathologically
- Surgery cannot be performed after evaluation
- Malignant tumors found in other parts within 5 years prior to or at enrollment
- Unwillingness to use clinical first-line targeted drugs
- Severe mental illness
- Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 36 months
Participants are observed to evaluate treatment efficacy and disease progression after receiving targeted maintenance therapy with PARP inhibitors.
Regular visits scheduled as per treatment plan
Duration - Over 5 years
Participants undergo long-term observation to assess overall survival and response to treatment over 5 years.
Follow-up visits over several years
Trial Site Locations
Total: 1 location
1
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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