- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2020-08-24
2024-10
2024-10
150
NCT05980221
University Hospital Birmingham NHS Foundation Trust
University Hospital Birmingham NHS Foundation Trust
INTERVENTIONAL
The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.
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. A test meal will be given to fasted participants alongside baseline blood samples and breath samples. Patients will then have blood and breath taken hourly for 6 hours. Blood samples will be spun and frozen for batch metabolomic analysis.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-05-31 | N/A | 2023-08-04 |
2023-08-04 | N/A | 2023-08-07 |
2023-08-07 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Pancreatic cancer (main cohort) investigation of PEI and the metabolome of patients with pancreatic cancer in the fed and fasted state | DIAGNOSTIC_TEST: Metabolomics
DIAGNOSTIC_TEST: 13C MTGT
|
| OTHER: Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs investigation of PEI and the metabolome of patients with other causes of PEI in the fed and fasted state | DIAGNOSTIC_TEST: Metabolomics
DIAGNOSTIC_TEST: 13C MTGT
|
| OTHER: Dosing arm Investigation metabolome of patients pre and post initiation of PERT as part of their PEI care | DIAGNOSTIC_TEST: Metabolomics
DIAGNOSTIC_TEST: 13C MTGT
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Metabolome | 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. | 1 year after study completion |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| PEI status using 13CMTGT in comparison to the metabolome | breath test (13CMTGT). 13C labelled fatty test meal ingested, exhaled breath samples eveyr hour up to 6 hours, the cumulative percent dose of 13C recovered will then be used as a marker for PEI, diagnostic under 29% | 1 year after study completion |
| PEI status using FE-1 in comparison to the metabolome | FE-1. Faecal elastase, diagnostic <200 | 1 year after study completion |
| PEI status using PEIQ in comparison to the metabolome | PEI-Q: Pancreatic exocrine insufficiency questionnaire (symptomatic assessment of PEI). >1.8 severe PEI, 1.4-1.8 moderate PEI, 0.6-1.4 mild PEI | 1 year after study completion |
| Response of the fed and fasted metabolome to PERT | Investigation of the metabolome in response to PERT low dose and high dose. The metabolomic profile indicative of PEI will then be assessed in a repeat cohort of patients that reattend twice on low dose and then high dose PERT. Bloods will be taken as for the main trial, in the fed and fasted state and the metabolomic profile (determined by the main cohort) will assessed using targeted liquid chromatography mass spectrometry to investigate whether it is altered by PERT (pancreatic exocrine replacement therapy) | 1 year after study completion |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sarah Powell-Brett, MBChB Phone Number: 07887754856 Email: sarah.powell-brett1@nhs.net |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
16 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
