Actively Recruiting
Drug Sensitivity Based on Hydrothorax and Ascite Organoids Derived from Metastatic Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-01-07
90
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating drug sensitivity in patients with metastatic breast cancer who have developed malignant hydrothorax and ascitic fluid, conditions that arise from cancer spreading to the lungs, pleura, or liver. These patients often face rapid disease progression, multidrug resistance, and limited treatment options. Current clinical guidelines suggest treatments based on molecular subtypes, but their effectiveness can be affected by previous therapies, patient health, and tumor changes. Traditional methods to evaluate treatment effects take two cycles, causing delays in identifying ineffective therapies and leading to unnecessary side effects and costs. Patient-derived organoid models offer a promising approach by closely mimicking tumor structure and cellular diversity, enabling better drug sensitivity testing and personalized treatment plans. In this study, 90 patients with metastatic breast cancer and associated hydrothorax and ascitic fluid will be enrolled. Samples of hydrothorax and ascitic fluid will be collected from each patient to create organoids. These organoids will then be exposed to standard chemotherapy drugs such as Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, as well as targeted therapies including Herceptin and Pertuzumab. The growth of organoids after treatment will be monitored, and dose-response curves will be generated to evaluate drug sensitivity. Participants will have their baseline medical history, ultrasound, and MRI data collected before and after two chemotherapy cycles. Tumor response will be assessed using RECIST criteria. Researchers will compare drug sensitivity results from the organoid tests with actual clinical outcomes to evaluate the accuracy of the organoid models in predicting treatment effectiveness. The study will also examine the sensitivity and specificity of organoid drug testing for treatment prediction. This observational study is expected to run from October 2024 to October 2026.
CONDITIONS
Brief Title
Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and willingness to participate in the clinical study.
- Patients aged between 18 and 70 years old.
- Confirmed metastatic breast cancer patients with hydrothorax and ascitic fluid verified to contain tumor cells.
- ECOG performance status score of 0 to 1.
- No significant abnormalities in liver and kidney function (bilirubin less than 1.5 times upper limit of normal; ALT less than 2.5 times ULN; AST less than 2.5 times ULN; creatinine less than or equal to 1 times ULN).
You will not qualify if you...
- Patients not suitable for chemotherapy and targeted therapy.
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.
1 visit (in-person)
Duration - Up to 2 weeks
Organoid drug testing is performed using tumor samples obtained from hydrothorax and ascitic fluid to assess drug sensitivity.
1 visit for sample collection
Duration - Approximately 6 months
Participants are observed with baseline data collected before and after two cycles of chemotherapy to evaluate tumor response and correlate with organoid drug sensitivity results.
2 visits for data collection (before and after chemotherapy cycles)
Trial Site Locations
Total: 3 locations
1
Second affiliated hospital of zhejiang university
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
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3
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310009
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Research Team
Z
ZHIGANG CHEN, MD
J
JIAN HUANG, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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