Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: pegylated liposomal doxorubicin


Participation Criteria
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Eligibility Criteria
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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; ECOG≤ 2; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment group<br>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. | Drug: pegylated liposomal doxorubicin<br>* All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.<br>* Other names: PLD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the consistency of circulating tumor DNA with CT scan | 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 | 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） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, pegylated liposomal doxorubicin, ovarian cancer