Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Progression free survival
研究概览
简要总结
The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes" aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response.
详细描述
The prospective clinical trial "PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes" aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response. Patients with histologically confirmed PDA are enrolled at primary diagnosis and prior to oncological or surgical treatment. Rectal and buccal microbiome swabs as well as detailed clinical records are obtained from all patients. Following DNA extraction, both 16S rRNA and metagenomic sequencing will be performed using ONT sequencing platform. All data and clinical records are centrally stored, visualized and integrated via tranSMART and SEEK platforms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients with pancreatic mass suspicious of pancreatic ductal adenocarcinoma
排除标准
- •< 18 years
- •patients that cannot give informed consent
- •pregnant and breastfeeding women
结局指标
主要结局
Progression free survival
时间窗: 12 months upon study enrollment
Progression free survival of patients measured in months
次要结局
- Molecular subtypes of pancreatic cancer(within 3 months of histological diagnosis)
- Response to chemotherapy(up to 6 months after start of therapy)
研究者
Albrecht Neesse
https://gastroenterologie.umg.eu/ueber-uns/team/neesse/
University Medical Center Goettingen
