Actively Recruiting
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Led by Tongji Hospital · Updated on 2024-08-13
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness of different treatments for patients with relapsed or persistent ovarian clear cell carcinoma (OCCC). This observational study aims to learn how well physician's choice of chemotherapy and immune checkpoint inhibitor (ICI)-based therapy work in real-world settings. It also compares these treatments to results from the INOVA clinical trial studying sintilimab plus bevacizumab combination therapy to see which approach may be more effective. The treatments being studied include two main groups: one receiving chemotherapy chosen by their physician and another receiving ICI-based therapy. Researchers will collect and analyze de-identified electronic health records (EHR) data from patients treated with these therapies. The study does not assign treatments but observes outcomes based on treatments patients have already received or are receiving. Participants will be observed through their medical records to measure outcomes like tumor response rate, progression-free survival, time to response, duration of response, and disease control rate over about one year. This study mainly involves following patients' health records without additional interventions or visits. The study is expected to end in May 2025 and includes female patients aged 18 to 75 years with a confirmed diagnosis of OCCC.
CONDITIONS
Brief Title
A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Histological diagnosis of ovarian clear cell carcinoma
- Recurrent or persistent ovarian clear cell carcinoma with at least one prior platinum-containing chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- Expected survival time of at least 12 weeks
You will not qualify if you...
- Histological evidence of non-ovarian clear cell carcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants receive physician's choice of chemotherapy or immune checkpoint inhibitor based therapy for relapsed/refractory ovarian clear cell carcinoma.
Visits as per treatment schedule determined by physician
Duration - Up to 1 year
Participants are monitored for tumor response, progression-free survival, time to response, duration of response, and disease control rate through study completion.
Periodic visits for assessment throughout study completion
Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qinglei Gao, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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