UK Early Detection Initiative for Pancreatic Cancer

Study ID: 42837
Short Title: UK-EDI: UK Early Detection Initiative for Pancreatic Cancer
Trust Name: DCHFT,DHC,PHU,SHFT,UHS
Recruitment Site: Blandford Community Hospital,Dorset County Hospital,Moorgreen Hospital,Queen Alexandra Hospital,Southampton General Hospital
Disease Area: Upper GI
Phase: N/A
Expected End Date: 31/03/2025
Postcode: DT1 2JY
BH17 0RB
PO6 3LY
SO40 2RZ
SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

1. Age > = 50 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.

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 three 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.

At the time of diagnosis of pancreatic cancer, an estimated 65% of patients have diabetes mellitus (DM). Whilst a small proportion of DM in pancreatic cancer patients is long standing (present more than 3 years) the remainder is new-onset-DM. This often goes undiagnosed, and when it is diagnosed, in the majority of cases this comes within one year prior to pancreatic cancer being identified. In effect, new-onset diabetes can be an early warning sign of the presence of pancreatic cancer, and individuals with new-onset diabetes are a high-risk group for pancreatic cancer. Approximately 1% of individuals (1 in 100) diagnosed with new onset type 2 DM (T2DM) have undiagnosed pancreatic cancer. This group of individuals actually has pancreatic cancer associated DM, although it is mistakenly diagnosed as T2DM. Currently individuals with new-onset DM are not screened for pancreatic cancer as there are no reliable tests to distinguish between T2DM and pancreatic cancer associated DM. 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 we 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. We 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 we will also attempt to gain a better understanding of risk factors associated with pancreatic cancer and to determin the cost effectiveness of screening for pancreatic cancer.

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