Prognostic Value of MRD Detection in CA125 Non-sensitive Ovarian Cancer Patients

Study Overview
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Brief Summary
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Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.

Official Title
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A Study for Assessing the Value of Minimal Residual Disease Detection in Disease Monitoring of CA125 Non-sensitive Ovarian Cancer Patients

Conditions
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Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75; Pathologically confirmed ovarian cancer; CA125 ≤200U/ml at first diagnosis or recurrence; Physical condition score PS ≤ 2 points; Enough tumor samples for WES detection; Patients and their families can understand and are willing to participate in this study and provide written informed consent. Exclusion Criteria: Patients unable to provide sufficient tissue / blood samples for research detection; Pregnant or lactating women; Other diseases considered by the research doctor to affect the prognosis and survival;
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ctDNA alternation during the treatment of Ovarian cancer<br>Tumor samples of included patients were detected by WES, and 16 major clonal mutation sites were screened for the personalized monitoring panel. All patients received blood ctDNA detection to monitor the major clonal alternation after 3 cycels treatment or 3 months after therapy, at the same time, the detection of serum tumor markers (CA125) and imaging examination were carried out, in order to evaluate the MRD detection efficiency. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prognostic value of MRD | The sensitivity of MRD in CA125 low level ovarian patients. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress Free Survival | PFS differences in patients with different MRD level | From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months |