CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer

Circulating Tumor DNA Clinical Trial

Official title:

Circulating Tumor DNA as a Novel Molecular Marker of Treatment Efficacy to Guide Targeted Maintenance Therapy for Patients With High Grade Serous Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027828
• Other study ID #: XH-21-008
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ovarian cancer first diagnosed and treated;

2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;

3. The stage of the disease is II-IV, and surgery will be performed after evaluation;

4. Age = 18 years old;

5. Subjects and their families fully understand the research plan and sign an informed consent form.

Exclusion Criteria:

1. Pathologically confirmed as non-epithelial ovarian cancer;

2. Surgical treatment cannot be performed after evaluation;

3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;

4. Patients who do not agree to use clinical first-line targeted drugs;

5. Severe mental illness;

6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Circulating Tumor DNA
• High-grade Serous Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.	about 36 months after using PARP inhibitors
Secondary	Overall survival		about over 5 years after using PARP inhibitors
Secondary	Objective response rate	To evaluate the general response of patients with ovarian cancer to PARP inhibitors	36 months after using PARP inhibitors