The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)

University Hospital Birmingham NHS Foundation Trust

Status: Enrolling

Conditions: Pancreatic Exocrine Insufficiency

Treatments: Diagnostic Test: Metabolomics; Diagnostic Test: 13C MTGT

Study type: Interventional

Funder types: Other

Identifiers

NCT05980221

RRK6813

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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+

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Pancreatic cancer (main cohort)

Other group

Description:

investigation of PEI and the metabolome of patients with pancreatic cancer in the fed and fasted state

Treatment:

Diagnostic Test: 13C MTGT

Diagnostic Test: Metabolomics

Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs

Other group

Description:

investigation of PEI and the metabolome of patients with other causes of PEI in the fed and fasted state

Treatment:

Diagnostic Test: 13C MTGT

Diagnostic Test: Metabolomics

Dosing arm

Other group

Description:

Investigation metabolome of patients pre and post initiation of PERT as part of their PEI care

Treatment:

Diagnostic Test: 13C MTGT

Diagnostic Test: Metabolomics