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

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

NCT ID: NCT05980221

Condition: Pancreatic Exocrine Insufficiency

Conditions: Official terms:
Exocrine Pancreatic Insufficiency

Conditions: Keywords:
exocrine insufficiency
pancreatic cancer
metabolomics
metabolites
chronic pancreatitis
cystic fibrosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Intervention model description: Investigating the metabolome of patients with PEI in the fasted and fed state. Prospective, single centre, observational study

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Metabolomics
Description: Plasma samples taken for the investigation of the metabolome
Arm group label: Dosing arm
Arm group label: Pancreatic cancer (main cohort)
Arm group label: Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs

Intervention type: Diagnostic Test
Intervention name: 13C MTGT
Description: sequential breath samples taken for investigation of PEI (reference test)
Arm group label: Dosing arm
Arm group label: Pancreatic cancer (main cohort)
Arm group label: Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs

Other name: 13C MTG breath test

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.

Criteria for 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+

Gender: All

Minimum age: 16 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University Hospitals Birmingham NHS Foundation Trust

Address:
City: Birmingham
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Sarah Powell-Brett, MBChB

Phone: 078877754856
Email: sarah.powell-brett1@nhs.net

Contact backup:
Last name: Keith Roberts, PhD
Email: keith.roberts@uhb.nhs.uk

Start date: August 24, 2020

Completion date: October 2024

Lead sponsor:
Agency: University Hospital Birmingham NHS Foundation Trust
Agency class: Other

Collaborator:
Agency: Pancreatic Cancer UK
Agency class: Other

Source: University Hospital Birmingham NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05980221