Pancreatic Exocrine InsufficiencyDETECTIONNCT05980221
The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
A study testing Metabolomics and 13C MTGT in people with Pancreatic Exocrine Insufficiency, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Exocrine Insufficiency
- What is being tested?
- Metabolomics and 13C MTGT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2020to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- CP
- PEI (as defined by breath test)
- Tolerating oral diet
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Sarah Powell-Brett, MBChB, 078877754856, sarah.powell-brett1@nhs.net
Keith Roberts, PhD, keith.roberts@uhb.nhs.uk
About this study
DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.
Read the 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.
- Conditions
- Pancreatic Exocrine Insufficiency
- Being tested
- Metabolomics, 13C MTGT
- Keywords
- exocrine insufficiency, pancreatic cancer, metabolomics, metabolites, chronic pancreatitis, cystic fibrosis
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatic Neoplasms, Pancreatitis, Chronic, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetabolomicsDiagnostic test
Plasma samples taken for the investigation of the metabolome
13C MTGTDiagnostic test
Also called 13C MTG breath test
sequential breath samples taken for investigation of PEI (reference test)
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer (main cohort) | Other | investigation of PEI and the metabolome of patients with pancreatic cancer in the fed and fasted state Receives: Diagnostic Test: Metabolomics; Diagnostic Test: 13C MTGT |
| Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs | Other | investigation of PEI and the metabolome of patients with other causes of PEI in the fed and fasted state Receives: Diagnostic Test: Metabolomics; Diagnostic Test: 13C MTGT |
| Dosing arm | Other | Investigation metabolome of patients pre and post initiation of PERT as part of their PEI care Receives: Diagnostic Test: Metabolomics; Diagnostic Test: 13C MTGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after study completion
Secondary outcomes (4)
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%
Measured: 1 year after study completion
PEI status using FE-1 in comparison to the metabolome
FE-1. Faecal elastase, diagnostic <200
Measured: 1 year after study completion
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
Measured: 1 year after study completion
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)
Measured: 1 year after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start24 Aug 2020
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Exocrine InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Investigating the metabolome of patients with PEI in the fasted and fed state. Prospective, single centre, observational study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pancreatic Cancer UK
- Responsible party
- Principal investigator, Keith John Roberts, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Keith Roberts, PhD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980221
- Sponsor's protocol ID
- RRK6813
- Acronym
- DETECTION
- Status last verified
- Aug 2023
- First submitted
- 31 May 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)
- ClinicalTrials.gov ID
- NCT05980221
- Acronym / sponsor ID
- DETECTION / RRK6813
- Conditions
- Pancreatic Exocrine Insufficiency
- Keywords
- exocrine insufficiency, pancreatic cancer, metabolomics, metabolites, chronic pancreatitis, cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Pancreatic Cancer UK
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Investigating the metabolome of patients with PEI in the fasted and fed state. Prospective, single centre, observational study
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer (main cohort) | Other | Diagnostic Test: Metabolomics, Diagnostic Test: 13C MTGTinvestigation of PEI and the metabolome of patients with pancreatic cancer in the fed and fasted state |
| Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs | Other | Diagnostic Test: Metabolomics, Diagnostic Test: 13C MTGTinvestigation of PEI and the metabolome of patients with other causes of PEI in the fed and fasted state |
| Dosing arm | Other | Diagnostic Test: Metabolomics, Diagnostic Test: 13C MTGTInvestigation metabolome of patients pre and post initiation of PERT as part of their PEI care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- PDAC
- PEI (as defined by breath test)
- Tolerating oral diet Inclusion Criteria: (for CF cohort)
- CF
- PEI (as defined by breath test)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetabolomicsPlasma samples taken for the investigation of the metabolome | Diagnostic test | Dosing arm, Pancreatic cancer (main cohort), Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs |
| 13C MTGTAlso: 13C MTG breath testsequential breath samples taken for investigation of PEI (reference test) | Diagnostic test | Dosing arm, Pancreatic cancer (main cohort), Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs |
Primary outcome
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.
4 secondary outcomes
PEI status using 13CMTGT in comparison to the metabolome
Time frame: 1 year after study completion
PEI status using FE-1 in comparison to the metabolome
Time frame: 1 year after study completion
PEI status using PEIQ in comparison to the metabolome
Time frame: 1 year after study completion
Response of the fed and fasted metabolome to PERT
Time frame: 1 year after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Roberts, PhD principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolomics and 13C MTGT in people with Pancreatic Exocrine Insufficiency, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Powell-Brett, MBChB (07887754856, sarah.powell-brett1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolome (time frame: 1 year after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.