Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer

NCT ID: NCT05976932

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-10-31

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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

pegylated liposomal doxorubicin

Intervention Type: DRUG

All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.

Interventions

pegylated liposomal doxorubicin

All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.

Intervention Type: DRUG

Other Intervention Names

PLD

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xiaohua Wu

Director,Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hao Wen, MD

Role: CONTACT

wenhao@shca.org.cn

+86-021-64175590 ext 81000

Xiaohua Wu, MD

Role: CONTACT

+86-021-64175590 ext 81000

Other Identifiers

2210263-1

Identifier Type: -

Identifier Source: org_study_id