跳至主要内容
临床试验/NCT04922515
NCT04922515Unknown不适用

Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

University Medical Center Goettingen4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月25日最近更新:
适应症

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

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

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Albrecht Neesse

https://gastroenterologie.umg.eu/ueber-uns/team/neesse/

University Medical Center Goettingen

研究点 (4)

Loading locations...

相似试验