Image

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

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

Recruiting
16 years and older
All
Phase N/A

Overview

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

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.

Eligibility

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 details
    Pancreatic Exocrine Insufficiency

NCT05980221

University Hospital Birmingham NHS Foundation Trust

13 December 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.