Ovarian Cancer
Conditions
Keywords
ctDNA, pegylated liposomal doxorubicin, ovarian cancer
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.
Interventions
DRUGpegylated liposomal doxorubicin
All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female, over 18 years of age; 2. Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer; 3. pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations; 4. ECOG≤ 2; 5. Expected survival time ≥3 months; 6. The subjects were able to understand the study process and voluntarily joined the study.
Exclusion criteria
1. Pregnant and lactating patients; 2. Patients with severe or uncontrolled infections; 3. Patients who are allergic or intolerant to the investigational drug; 4. Patients who are enrolled in or within a month of another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the consistency of circulating tumor DNA with CT scan | 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 |
Contacts
Primary ContactHao Wen, MD
Backup ContactXiaohua Wu, MD
Outcome results
None listed