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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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High-grade Serous Ovarian Cancer Circulating Tumor DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients using olaparib only

No interventions assigned to this group

patients using olaparib combined with bevacizumab

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xipeng Wang, Dr

Role: primary

[email protected]

25078999

Other Identifiers

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XH-21-008

Identifier Type: -

Identifier Source: org_study_id