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

NCT05027828 | Recruiting DMC

• 1 other identifier: XH-21-008
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High-grade Serous Ovarian Cancer; Circulating Tumor DNA

Outcome Measures

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.

  about 36 months after using PARP inhibitors

Secondary Outcomes (2)

• Overall survival

  about over 5 years after using PARP inhibitors

• Objective response rate

  36 months after using PARP inhibitors

Study Arms (2)

patients using olaparib only

patients using olaparib combined with bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and whole blood cells

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 30, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)