Establishing Organoids From Metastatic Pancreatic Cancer Patients, the OPT-I Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Developing organoids from advanced pancreatic cancer patients that predict non response or response
研究概览
简要总结
Rationale: Pancreatic adenocarcinoma is a malignancy with a poor prognosis. Resection is the only curative option and still 5-year survival rate is less than 10 percent. However, most patients present with advanced disease and are provided with palliative care. The nature of the tumour and the intense stromal reaction around the tumour cells leave pancreatic adenocarcinoma relatively insensitive to chemotherapeutics. Current models, such as cell lines or patient derived xenografts, cannot provide predictive information in a clinically relevant timeframe. Organoids and organotypic culture systems have emerged as promising new culturing techniques that maintain some of the complexity of the tumour. As most patients are ineligible for tumour resection, this project will focus on metastases and will generate organoids from that tissue. Using a combination of organoids and organotypic systems, treatment (non)response can be predicted, which may provide a personalized treatment setting for patients with advanced pancreatic adenocarcinoma.
详细描述
Rationale: Pancreatic adenocarcinoma is a malignancy with a poor prognosis. Resection is the only curative option and still 5-year survival rate is less than 10 percent. However, most patients present with advanced disease and are provided with palliative care. The nature of the tumour and the intense stromal reaction around the tumour cells leave pancreatic adenocarcinoma relatively insensitive to chemotherapeutics. Current models, such as cell lines or patient derived xenografts, cannot provide predictive information in a clinically relevant timeframe. Organoids and organotypic culture systems have emerged as promising new culturing techniques that maintain some of the complexity of the tumour. As most patients are ineligible for tumour resection, this project will focus on metastases and will generate organoids from that tissue. Using a combination of organoids and organotypic systems, treatment (non)response can be predicted, which may provide a personalized treatment setting for patients with advanced pancreatic adenocarcinoma.
Objective: To develop a model system and infrastructure to individualize the treatment of patients with advanced pancreatic adenocarcinoma. Additionally, we aim to identify predictors of therapy (non)response.
Study design: Observational laboratory studies (with DNA/RNA isolation, RNA sequencing, cell culturing, organoid culturing and xenografting) will be performed with tumour specimens. These organoids will be stored for future research.
Study population: All adult patients (> 18 years) with (a suspicion of) advanced pancreatic adenocarcinoma
Main study parameters/endpoints: The development of organoids from biopsies of metastases or primary tumour tissue of pancreatic cancer that correlate with clinical response. These models are then analysed for the expression of bio markers in organoid, organotypic and xenograft models. DNA/RNA profiles will be correlated to clinical and pathological characteristics such as therapy response, survival and TNM classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Diagnosed with locally advanced pancreatic cancer or metastatic pancreatic cancer
- •Able to understand the information given
排除标准
- •Unfit for biopsies & blood analyses
- •Not able to give informed consent (language, intellectual capacities, etc.)
结局指标
主要结局
Developing organoids from advanced pancreatic cancer patients that predict non response or response
时间窗: 2 months
To assess whether there is a correlation between no response in patients and no response in organoids, a goodness of fit will be determined with Pearson's X2 test. Depending on the available data, the second scenario will be analysed similarly. When organoids cannot be established from biopsy material, then this will be recorded and linked to clinical parameters.
次要结局
- Functional studies will be done with the patient derived organoids to find biomarkers that correlate with response in organoids and patients.(2 months)
研究者
J.W. Wilmink
M.D. PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)