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

Primary Purpose

Pancreatic Exocrine Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Metabolomics
13C MTGT
Sponsored by
University Hospital Birmingham NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Exocrine Insufficiency focused on measuring exocrine insufficiency, pancreatic cancer, metabolomics, metabolites, chronic pancreatitis, cystic fibrosis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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+

Sites / Locations

  • University Hospitals Birmingham NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Pancreatic cancer (main cohort)

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

Dosing arm

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%
PEI status using FE-1 in comparison to the metabolome
FE-1. Faecal elastase, diagnostic <200
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
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)

Full Information

First Posted
May 31, 2023
Last Updated
August 4, 2023
Sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborators
Pancreatic Cancer UK
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1. Study Identification

Unique Protocol Identification Number
NCT05980221
Brief Title
The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
Acronym
DETECTION
Official Title
The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborators
Pancreatic Cancer UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Exocrine Insufficiency
Keywords
exocrine insufficiency, pancreatic cancer, metabolomics, metabolites, chronic pancreatitis, cystic fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Investigating the metabolome of patients with PEI in the fasted and fed state. Prospective, single centre, observational study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pancreatic cancer (main cohort)
Arm Type
Other
Arm Description
investigation of PEI and the metabolome of patients with pancreatic cancer in the fed and fasted state
Arm Title
Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs
Arm Type
Other
Arm Description
investigation of PEI and the metabolome of patients with other causes of PEI in the fed and fasted state
Arm Title
Dosing arm
Arm Type
Other
Arm Description
Investigation metabolome of patients pre and post initiation of PERT as part of their PEI care
Intervention Type
Diagnostic Test
Intervention Name(s)
Metabolomics
Intervention Description
Plasma samples taken for the investigation of the metabolome
Intervention Type
Diagnostic Test
Intervention Name(s)
13C MTGT
Other Intervention Name(s)
13C MTG breath test
Intervention Description
sequential breath samples taken for investigation of PEI (reference test)
Primary Outcome Measure Information:
Title
Metabolome
Description
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.
Time Frame
1 year after study completion
Secondary Outcome Measure Information:
Title
PEI status using 13CMTGT in comparison to the metabolome
Description
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%
Time Frame
1 year after study completion
Title
PEI status using FE-1 in comparison to the metabolome
Description
FE-1. Faecal elastase, diagnostic <200
Time Frame
1 year after study completion
Title
PEI status using PEIQ in comparison to the metabolome
Description
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
Time Frame
1 year after study completion
Title
Response of the fed and fasted metabolome to PERT
Description
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)
Time Frame
1 year after study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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+
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Powell-Brett, MBChB
Phone
07887754856
Email
sarah.powell-brett1@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Roberts, PhD
Organizational Affiliation
University Hospital Birmingham NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Powell-Brett, MBChB
Phone
078877754856
Email
sarah.powell-brett1@nhs.net
First Name & Middle Initial & Last Name & Degree
Keith Roberts, PhD
Email
keith.roberts@uhb.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

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

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