Unique Protocol ID | SGOG TR1/XH-21-008 |
ClinicalTrials.gov ID | ClinicalTrials.gov Identifier: NCT05027828 |
Version Number | NCT05027828 |
IRB ID |
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Data Monitoring Committee: | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Brief Title: | CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer |
Official 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 |
Study Type： | Observational prospective cohort |
Secondary IDs | No |
Responsible Party： | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Sponsor： | Beijing Kanghua Traditional Chinese and Western Medicine Development Foundation |
Collaborators: | No |
Brief Summary: | Primary ovarian cancer with stage II-IV of high-grade serous ovarian cancer（HGOC）were recruited in this study. Plasma was collected and MRD was detected. |
Detailed Description: | 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 and detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the MRD and efficacy of in patients with ovarian cancer, and to detect the recurrence of the disease early. |
Study Start Date: | April 1, 2023 |
Primary Completion Date： | August 30, 2024 |
Study Completion Date: | September 30, 2024 |
Study Design: | Observational prospective cohort |
Outcome Measures: | 1.Progression-free survival; 2. Overall survival;3. Objective response |
Conditions: | No |
Keywords: | Ovarian cancer, ctDNA, biomarker |
Arms: | Multi-armed |
Intervention Description: | Patients using olaparib only or patients using olaparib combined with bevacizumab |
Interventions: |
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Eligibility Criteria: | Primary ovarian cancer |
Gender： | No |
Minimum Age: | 18 Years |
Maximum Age: | No |
Accepts Healthy Volunteers: | No |
Sample size | 50 |
Central Contact： | 2 |
Principal Investigators | Xipeng,Wang |
Locations: | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China |
Recruitment Status: | Recruiting |
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