NCT02050997终止不适用
Identification of Predictive Plasma Biomarkers in Pancreatic Ductal Adenocarcinoma (PDAC Plasma Biomarker Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 169
- 试验地点
- 9
- 主要终点
- Time to disease recurrence
研究概览
简要总结
This is an exploratory, translational, non-interventional and multi-centre clinical study. The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in PDAC.
详细描述
This study will involve two cohort groups, all patients involved will have PDAC.
Cohort A: Target is 80 resectable PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy
Cohort B:
- Cohort B1 = Target is 80 unresectable locally advanced PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.
- Cohort B2 = Target is metastatic PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.
Control patients: Target is 50, with acute pancreatitis admitted to hospital for observation/treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years of age
- •Ability to give written informed consent
- •Histologically or cytologically-confirmed PDAC
- •Patients who will receive standard treatment of CT +/- radiotherapy and present with:
- •Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2
排除标准
- •Presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study
结局指标
主要结局
Time to disease recurrence
时间窗: Blood samples analysed up to 2 year follow up, estimated 4 years in total
Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence
次要结局
- Rate of progression free survival(Blood samples analysed up to 2 year follow up, estimated 4 years in total)
- Accuracy, sensitivity, specificity and concordance index(For the duration of study, expected 4 years)
研究者
研究点 (9)
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