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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Newly-diagnosed and treated patients with high-grade serous ovarian cancer who will receive PARP inhibitors as first-line maintenance therapy after surgery and traditional chemotherapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: patients using olaparib only
Group B: patients using olaparib combined with bevacizumab

Trial outcomes

Primary outcomes

1

Progression-free survival

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.

Time frame
about 36 months after using PARP inhibitors

Secondary outcomes

1

Overall survival

Time frame
about over 5 years after using PARP inhibitors
2

Objective response rate

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

Time frame
36 months after using PARP inhibitors

Other outcomes

Sponsors and contacts

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