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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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
View:

• 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.

Locations
Other Locations
China
west china second University, SICHUAN University, China
RECRUITING
Chengdu
Contact Information
Primary
Rutie Yin
yrtt2013@163.com
028-88570403
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 35
Treatments
ctDNA alternation during the treatment of Ovarian cancer
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.
Related Therapeutic Areas
Sponsors
Leads: West China Second University Hospital

This content was sourced from clinicaltrials.gov