The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Metabolome
研究概览
简要总结
DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.
详细描述
Pancreatic exocrine insufficiency (PEI) is prevalent and progressive among patients with pancreatic cancer, treatment with pancreatic enzyme replacement therapy (PERT) has been proven to reduce gastrointestinal symptoms, improve quality of life and survival and is therefore recommended in NICE guidelines. Despite this, most patients with PEI do not receive PERT.
One cause for under treatment is lack of a well-tolerated and accurate diagnostic test that can provide quick results. The current, most widely used test, the faecal elastase stool test, has low accuracy, particularly after surgery, and results take several days. Furthermore, the test cannot help with dosing of PERT.
Metabolomics can be used to quantify metabolites in blood. These metabolites are directly influenced by normal digestion and absorption of food, for example blood lipid levels are very different in the fed and fasted states. This program of work will give a standard meal to healthy controls and patients with PEI and screen their blood before and after a test meal. Differences in the metabolic profile will be used to develop a 'fingerprint' of PEI based upon one metabolite or a combination of metabolites.
The ultimate goal is to develop a simple blood test that can be used outside of specialist centres that is acceptable to patients, can accurately diagnose PEI and can guide treatment with PERT.
This body of work aims to investigate the metabolome of patients with PEI (of different causes), PEI will be defined in the different cohorts by a multimodel approach with the 13C MTGT as primary reference test and FE-1 and PEI-Q used as supporting tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(for main pancreatic cancer cohort)
- •PEI (as defined by breath test)
- •Tolerating oral diet Inclusion Criteria: (for CF cohort)
- •PEI (as defined by breath test)
- •Tolerating oral diet Inclusion Criteria: (for CP cohort)
- •PEI (as defined by breath test)
- •Tolerating oral diet
排除标准
- •(all arms):
- •No other GI conditions
- •For each arm no evidence of the other arm conditions
- •For health controls, no history of CP, CF or pancreatic cancer
- •No GI surgery (except pancreatic resection in the pancreatic cancer cohort)
- •Unable to consent
- •Unable to travel to UHB for testing
- •Prognosis < 2months
- •Performance status 2+
结局指标
主要结局
Metabolome
时间窗: 1 year after study completion
metabolomic fingerprint of patient with PEI in the fed and fasted state Bloods are taken in the fed and fasted state, after centrifugation, the plasma is then frozen at -80. Samples will then be analysed using untargeted liquid chromatography mass spectrometry, after which the raw data will be processed using the open-source software XCMS. The resultant metabolite features in the samples will be compared between healthy and diseased (PEI) cohorts to identify features specific to exocrine insufficiency.
次要结局
- PEI status using FE-1 in comparison to the metabolome(1 year after study completion)
- PEI status using 13CMTGT in comparison to the metabolome(1 year after study completion)
- PEI status using PEIQ in comparison to the metabolome(1 year after study completion)
- Response of the fed and fasted metabolome to PERT(1 year after study completion)
研究者
Keith John Roberts
Consultant HPB and transplant surgeon
University Hospital Birmingham NHS Foundation Trust