Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05976932
• Other study ID #: 2210263-1
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: October 2024

Study information

• Verified date: August 2023
• Source: Fudan University
• Contact: Hao Wen, MD
• Phone: +86-021-64175590 ext 81000
• Email: wenhao[@]shca.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)