CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer

NCT05027828 — Recruiting, 100 participants, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer

Registry	NCT05027828
Status	Recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Conditions	High-grade Serous Ovarian Cancer, Circulating Tumor DNA
Dates	start 2021-09-01, primary completion 2027-04-30 (estimated), completion 2027-09-30 (estimated), first posted 2021-08-30, last updated 2026-04-24
Locations	1 site in China

-Summary

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.

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+Arms and interventions

Arm	Type	Interventions	Description
patients using olaparib only
patients using olaparib combined with bevacizumab

+Outcome measures

Primary outcomes

Progression-free survival [about 36 months after using PARP inhibitors]: To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.

Secondary outcomes

Overall survival [about over 5 years after using PARP inhibitors]
Objective response rate [36 months after using PARP inhibitors]: To evaluate the general response of patients with ovarian cancer to PARP inhibitors

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	China	Recruiting