NCT05980221

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

4.1 years

First QC Date

May 31, 2023

Last Update Submit

August 4, 2023

Conditions

Pancreatic Exocrine Insufficiency

Keywords

exocrine insufficiencypancreatic cancermetabolomicsmetaboliteschronic pancreatitiscystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year after study completion

Secondary Outcomes (4)

  • PEI status using 13CMTGT in comparison to the metabolome

    1 year after study completion

  • PEI status using FE-1 in comparison to the metabolome

    1 year after study completion

  • PEI status using PEIQ in comparison to the metabolome

    1 year after study completion

  • Response of the fed and fasted metabolome to PERT

    1 year after study completion

Study Arms (3)

Pancreatic cancer (main cohort)

OTHER

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

Diagnostic Test: MetabolomicsDiagnostic 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

Diagnostic Test: MetabolomicsDiagnostic Test: 13C MTGT

Dosing arm

OTHER

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

Diagnostic Test: MetabolomicsDiagnostic Test: 13C MTGT

Interventions

MetabolomicsDIAGNOSTIC_TEST

Plasma samples taken for the investigation of the metabolome

Dosing armPancreatic cancer (main cohort)Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs
13C MTGTDIAGNOSTIC_TEST

sequential breath samples taken for investigation of PEI (reference test)

Also known as: 13C MTG breath test
Dosing armPancreatic cancer (main cohort)Sub-study cohorts: Chronic pancreatitis, cystic fibrosis, NET patients on SSAs

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PDAC
  • PEI (as defined by breath test)
  • PEI (as defined by breath test)
  • PEI (as defined by breath test)
  • Tolerating oral diet

You may not qualify if:

  • 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+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Exocrine Pancreatic InsufficiencyPancreatic NeoplasmsPancreatitis, ChronicCystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Keith Roberts, PhD

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Powell-Brett, MBChB

CONTACT

07887754856sarah.powell-brett1@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Investigating the metabolome of patients with PEI in the fasted and fed state. Prospective, single centre, observational study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant HPB and transplant surgeon

Study Record Dates

First Submitted

May 31, 2023

First Posted

August 7, 2023

Study Start

August 24, 2020

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

GB(1)