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UK early detection initiative for pancreatic cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12805385
Enrollment
1000
Registered
2020-02-13
Start date
2021-02-08
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer Cancer Malignant neoplasm of pancreas

Interventions

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.
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 re

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 09/07/2025: 1. Diagnosis or treatment of pancreatic cancer, peri pancreatic cancer or pancreatic endocrine cancer. 2. Previous surgical resection of the pancreas 3. Diagnosis of diabetes > 6 months before study entry 4. Pregnancy 5. Condition preventing study investigation and follow-up 6. Inability or incapacity to give informed consent _____ Previous 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, Northern Ireland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026