Clinical trial NCT05980221: The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
Official title: The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Exocrine Insufficiency
Keywords: exocrine insufficiency
pancreatic cancer
metabolomics
metabolites
chronic pancreatitis
cystic fibrosis
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Pancreatic Cancer UK
First posted: 2023-08-07
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Investigating the metabolome of patients with PEI in the fasted and fed state. Prospective, single centre, observational study
Primary purpose: DIAGNOSTIC

Brief summary: DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: (for main pancreatic cancer cohort)

* PDAC
* PEI (as defined by breath test)
* Tolerating oral diet Inclusion Criteria: (for CF cohort)
* CF
* PEI (as defined by breath test)
* Tolerating oral diet Inclusion Criteria: (for CP cohort)
* CP
* PEI (as defined by breath test)
* Tolerating oral diet

Exclusion Criteria (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+

Primary outcomes:
measure: Metabolome
timeFrame: 1 year after study completion
Secondary outcomes:
measure: PEI status using 13CMTGT in comparison to the metabolome
timeFrame: 1 year after study completion
measure: PEI status using FE-1 in comparison to the metabolome
timeFrame: 1 year after study completion
measure: PEI status using PEIQ in comparison to the metabolome
timeFrame: 1 year after study completion
measure: Response of the fed and fasted metabolome to PERT
timeFrame: 1 year after study completion
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Keith Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: