Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: pegylated liposomal doxorubicin

• Registration Number: NCT05976932
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2023-06-30
• Status Verified: 2023-08
• Study Start: 2023-08
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Primary Completion: 2024-04
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treatment group	pegylated liposomal doxorubicin	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.

Primary Outcome Measures

Name	Time	Method
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