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

August 4, 2023 updated by: Keith John Roberts, University Hospital Birmingham NHS Foundation Trust
DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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
Plasma samples taken for the investigation of the metabolome
Diagnostic test: 13C MTGT
sequential breath samples taken for investigation of PEI (reference test)
Other Names:
  • 13C MTG breath test
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
Plasma samples taken for the investigation of the metabolome
Diagnostic test: 13C MTGT
sequential breath samples taken for investigation of PEI (reference test)
Other Names:
  • 13C MTG breath test
Other: Dosing arm
Investigation metabolome of patients pre and post initiation of PERT as part of their PEI care
Diagnostic test: Metabolomics
Plasma samples taken for the investigation of the metabolome
Diagnostic test: 13C MTGT
sequential breath samples taken for investigation of PEI (reference test)
Other Names:
  • 13C MTG breath test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolome
Time Frame: 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.
1 year after study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEI status using 13CMTGT in comparison to the metabolome
Time Frame: 1 year after study completion
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
Time Frame: 1 year after study completion
FE-1. Faecal elastase, diagnostic <200
1 year after study completion
PEI status using PEIQ in comparison to the metabolome
Time Frame: 1 year after study completion
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
Time Frame: 1 year after study completion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Collaborators

Pancreatic Cancer UK

Investigators

  • Principal Investigator: Keith Roberts, PhD, University Hospital Birmingham NHS Foundation Trust

Study record dates

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 Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK6813

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Exocrine Insufficiency

Clinical Trials on Metabolomics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe