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Trial Title:
Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer
NCT ID:
NCT05976932
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Doxorubicin
Liposomal doxorubicin
Conditions: Keywords:
ctDNA
pegylated liposomal doxorubicin
ovarian cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
pegylated liposomal doxorubicin
Description:
All eligible subjects will receive the standard chemotherapy of pegylated liposomal
doxorubicin monotherapy.
Arm group label:
treatment group
Other name:
PLD
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.
Criteria for eligibility:
Study pop:
platinum-resistant ovarian cancer
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2023
Completion date:
October 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976932
