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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2024-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pancreatic Cancer Dietary Assessment Study

NCT03616431

Pancreatic Neoplasm Pancreas Adenocarcinoma Well-Differentiated Neuroendocrine Carcinoma +1 more

COMPLETED

Surveillance of Pancreatic Health After Diabetes Diagnosis

NCT06803771

Diabetes Mellitus Pancreatic Cancer, Adult

RECRUITING NA

Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations

NCT06041009

Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Elastase 1 +3 more

RECRUITING

Pancreatitis - Microbiome as Predictor of Severity II

NCT06508502

Acute Pancreatitis Acute Pancreatitis With Infected Necrosis

RECRUITING

Pancreatic Cancer Early Detection Registry

NCT05519930

Pancreatic Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Exocrine Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pancreatic cancer (main cohort)

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

Group Type OTHER