CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: High-grade Serous Ovarian Cancer, Circulating Tumor DNA. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Progression-free survival [Time frame: about 36 months after using PARP inhibitors]
Secondary outcome measures (2)
- Overall survival [Time frame: about over 5 years after using PARP inhibitors]
- Objective response rate [Time frame: 36 months after using PARP inhibitors]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT05027828 · XH-21-008