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

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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Key information

Conditions

High-grade Serous Ovarian Cancer Circulating Tumor DNA

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Xipeng Wang, Dr

CONTACT

[email protected]

25078999

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ovarian cancer first diagnosed and treated;
Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
The stage of the disease is II-IV, and surgery will be performed after evaluation;
Age ≥ 18 years old;
Subjects and their families fully understand the research plan and sign an informed consent form.

Exclusion criteria

Pathologically confirmed as non-epithelial ovarian cancer;
Surgical treatment cannot be performed after evaluation;
Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
Patients who do not agree to use clinical first-line targeted drugs;
Severe mental illness;
Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.

Treatment and study plan

Primary outcomes

Progression-free survival

Time frame: 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

Time frame: about over 5 years after using PARP inhibitors
Objective response rate

Time frame: 36 months after using PARP inhibitors

To evaluate the general response of patients with ovarian cancer to PARP inhibitors

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Aug 30, 2021
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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