RecruitingNCT05027828

CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With 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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

100 participants

Start Date

Sep 1, 2021

Study Type

OBSERVATIONAL

Conditions

Circulating Tumor DNA High Grade Serous Ovarian Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.