The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
Overview
- Phase
- Not Applicable
- Intervention
- pegylated liposomal doxorubicin
- Conditions
- Ovarian Cancer
- Sponsor
- Fudan University
- Enrollment
- 20
- Primary Endpoint
- the consistency of circulating tumor DNA with CT scan
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This observational study is conducted to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
Detailed Description
The goal of this study is to assess the utility of circulating tumor DNA in monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a single-arm, single-center prospective clinical study. After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA will be tested for genetic variation based on next-generation sequencing (NGS). Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging and CA125 in platinum-resistant ovarian cancer.
Investigators
Xiaohua Wu
Director,Clinical Professor
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Female, over 18 years of age;
- •Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
- •pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
- •Expected survival time ≥3 months;
- •The subjects were able to understand the study process and voluntarily joined the study.
Exclusion Criteria
- •Pregnant and lactating patients;
- •Patients with severe or uncontrolled infections;
- •Patients who are allergic or intolerant to the investigational drug;
- •Patients who are enrolled in or within a month of another clinical trial.
Arms & Interventions
treatment group
After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.
Intervention: pegylated liposomal doxorubicin
Outcomes
Primary Outcomes
the consistency of circulating tumor DNA with CT scan
Time Frame: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
measuring the mutations of TP53，reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes，calculating Kappa value，and conducting a intrarater reliability