Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer

NCT05976932 | Unknown

• 1 other identifier: 2210263-1
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cancer

Keywords

ctDNA; pegylated liposomal doxorubicin; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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）

Study Arms (1)

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.

Drug: pegylated liposomal doxorubicin

Interventions

pegylated liposomal doxorubicin DRUG

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

Also known as: PLD

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

platinum-resistant ovarian cancer

You may qualify if:

• Female, over 18 years of age;
• Patients with histopathological diagnosis of high-grade serous epithelial ovarian cancer;
• pathological report:phenotype of p53 mutation；or previous genetic tests of tumor tissue indicated TP53 gene mutations;
• ECOG≤ 2;
• Expected survival time ≥3 months;
• The subjects were able to understand the study process and voluntarily joined the study.

You may not qualify if:

• Pregnant and lactating patients;
• Patients with severe or uncontrolled infections;
• Patients who are allergic or intolerant to the investigational drug;
• Patients who are enrolled in or within a month of another clinical trial.

Sponsors & Collaborators

• Fudan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicin; 1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Hao Wen, MD

CONTACT

+86-021-64175590 ext 81000; wenhao@shca.org.cn

Xiaohua Wu, MD

CONTACT

+86-021-64175590 ext 81000

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Clinical Professor

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 4, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share