Condition category
Cancer
Date applied
13/01/2020
Date assigned
13/02/2020
Last edited
14/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
At the time of diagnosis of pancreatic cancer, an estimated 65% of patients have diabetes mellitus. Whilst in some individuals with pancreatic cancer the diabetes is long-standing, the remainder is new-onset diabetes. This often goes undiagnosed and when it is diagnosed, in the majority of cases the diabetes develops within one year prior to pancreatic cancer being identified. New-onset diabetes can therefore be an early warning sign in a proportion of individuals of the presence of pancreatic cancer.
Only a small proportion of individuals who develop new-onset diabetes (1 in 100) develop the diabetes as a result of undiagnosed pancreatic cancer. Currently there are no reliable tests to identify which individuals have developed diabetes as a result of undiagnosed pancreatic cancer. It is therefore not possible to screen everybody who develops new-onset diabetes to test if this is as a result of having pancreatic cancer.
This study aims to recruit 2500 individuals with new-onset diabetes in order to collect blood samples and clinical data. The researchers hope to identify biomarkers in the blood that will be able to distinguish if diabetes has been caused by pancreatic cancer or not. The researchers will also attempt to gain a better understanding of risk factors associated with pancreatic cancer and to determine the cost-effectiveness of screening for pancreatic cancer. This may ultimately enable a screening programme in the future.

Who can participate?
Patients aged 50 or over with new-onset diabetes diagnosed within 6 months of study entry, no previous history of pancreatic cancer, no previous surgery of the pancreas, and no previous treatment for digestive or endocrine cancer within 5 years of study entry

What does the study involve?
The study involves attending the research site on five occasions six months apart. Blood samples for research and clinical data are collected at each visit

What are the possible benefits and risks of participating?
This is an observational scientific research study. It is unlikely that the study will be of direct benefit to participants. It is hoped however that this research will eventually lead to improvements in screening for, and diagnosis of, pancreatic cancer. There may be some minor but short-lasting discomfort when providing a blood sample

Where is the study run from?
The study is co-ordinated by the Liverpool Clinical Trials Centre within the University of Liverpool (UK)

When is the study starting and how long is it expected to run for?
April 2019 to March 2024

Who is funding the study?
Cancer Research UK

Who is the main contact?
Mr Robert Hanson
ukedi@liverpool.ac.uk

Lay summary under review with external organisation

Trial website

http://www.uk-edi.co.uk

Contact information

Type

Scientific

Primary contact

Mr Robert Hanson

ORCID ID

Contact details

University of Liverpool
Liverpool Clinical Trials Centre
1st Floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)151 794 8852
ukedi@liverpool.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 42837, IRAS 258093

Study information

Scientific title

UK Early Detection Initiative for pancreatic cancer (UK-EDI)

Acronym

UK-EDI

Study hypothesis

Developing methods for pancreatic cancer detection in individuals with new-onset DM will require early-stage, pre-diagnostic samples and corresponding patient data. In this study, the researchers aim to recruit 2500 Individuals from hospitals and GP surgeries who are 50 years old or over and newly diagnosed with DM. Blood samples and questionnaire/clinical data will be collected at appointments every six months for two years. The researchers will collect and store samples in a standardised way so that they can be used to identify biomarkers in the blood that will distinguish between DM caused by pancreatic cancer and type 2 DM. This may ultimately enable a screening programme in the future.

As part of this study, the researchers will also attempt to gain a better understanding of risk factors associated with pancreatic cancer and to determine the cost-effectiveness of screening for pancreatic cancer.

Ethics approval

Approval pending, ref: 20/LO/0058

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Pancreatic cancer

Intervention

A prospective cohort design will be used to recruit a patient cohort with new-onset diabetes of 50 years of age or over. Biological samples along with demographic and clinical data will be collected. These data will be collected with the aim of establishing biomarkers that may assist in identifying pancreatic cancer at an earlier stage.

Following confirmation of eligibility, participants are registered onto the study. Participants will attend for five study-specific visits: baseline, 6 months from baseline, 12 months 18 months and 24 months.

At each visit participants will provide a blood sample for HbA1c analysis and donate blood samples for biomarker translational work. Participants will be asked to provide data on demographics, medical and drug history and to complete two questionnaires; EQ-5D-5L and the Diabetes Self Management Questionnaire (DSMQ).

A final national database search will be conducted at 36 months for each participant to establish their health status. This will not require participant attendance as a distinct research visit.

Intervention type

Other

Phase

Drug names

Primary outcome measure

As a scientific discovery study, there is no powered hypothesis test, however, the key clinical information the researchers are collecting is to define the incidence of pancreatic cancer in the UK of individuals with new-onset diabetes. This is measured by confirmed clinical diagnosis of pancreatic cancer at 36 months from recruitment.

Secondary outcome measures

As a scientific discovery study, there is no powered hypothesis test. The key clinical information the researchers are collecting is;
1. HbA1c measured using standard test on blood samples collected at baseline, 6, 12, 18 and 24 months
2. Quality of life measured using EQ-5D-5L at baseline, 6, 12, 18 and 24 months
3. Diabetes self-care activities measured using the Diabetes Self Management Questionnaire (DSMQ) at baseline, 6, 12, 18 and 24 months

Overall trial start date

01/04/2019

Overall trial end date

31/03/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age > = 50 years at time of study entry
2. New-onset diabetes (defined as HbA1C > = 48mmol/mol (6.5%)) diagnosed within 6 months of study entry
3. Written informed consent obtained from the participant prior to performing any protocol-related procedures
4. Participant is willing and able to comply with the protocol for the duration of the study including scheduled follow-up visits

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2,500; UK Sample Size: 2,500

Participant exclusion criteria

1. Diagnosis of pancreatic cancer within 5 years of study entry
2. Treatment for digestive or endocrine cancer within 5 years of study entry
3. Previous surgical resection of the pancreas
4. A known history of hyperglycaemia/pre-diabetes (HbA1c: 42-47 mmol/mol (5.9% - 6.4%)) of greater than 3 years duration
5. Diagnosis of diabetes > 6 months before study entry
6. Pregnancy
7. Condition preventing study investigation and follow-up
8. Inability or incapacity to give informed consent

Recruitment start date

01/03/2020

Recruitment end date

30/06/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Royal Liverpool and Broadgreen University Hospitals NHS Trust Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

Royal Free Hospital
Royal Free London NHS Foundation Trust Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

The Royal London Hospital
Barts Health NHS Trust Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford University Hospitals NHS Foundation Trust Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham University Hospitals NHS Trust Trust Headquarters Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

The Countess Of Chester Hospital
Countess Of Chester Hospital NHS Foundation Trust Health Park
Chester
CH2 1UL
United Kingdom

Trial participating centre

St. James's University Hospital
Leeds Teaching Hospitals NHS Trust Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

Abertawe Bro Morgannwg University LHB
One Talbot Gateway Seaway Drive Seaway Parade Industrial Estate Baglan
Port Talbot
SA12 7BR
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

c/o Alex Astor
Research Support Office
2nd Floor Block D Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)1517948739
sponsor@liv.ac.uk

Sponsor type

University/education

Website

http://www.liv.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK; Grant Codes: C7690/A26881

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Study protocol, statistical analysis plan not currently available. The researchers intend to publish the protocol subject to successful REC review
2. Peer-reviewed scientific journals
3. Internal report
4. Conference presentation
5. Publication on website

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/04/2025

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/02/2020: Internal review. 13/01/2020: Trial's existence confirmed by the NIHR.