Status:

RECRUITING

Surveillance of Pancreatic Health After Diabetes Diagnosis

Lead Sponsor:

University Hospital Southampton NHS Foundation Trust

Collaborating Sponsors:

ClearNote Health

Conditions:

Diabetes Mellitus

Pancreatic Cancer, Adult

Eligibility:

All Genders

50-84 years

Phase:

NA

Brief Summary

The goal of this interventional study is to evaluate if the novel diagnostic blood test, called Avantect can early detect pancreatic cancer in patients diagnosed with type 2 diabetes within the last 6...

Detailed Description

Pancreatic cancer (PC) is one of the most lethal common cancers (five-year survival 5-7%). In more than 80% of patients the disease has spread before it is detected, ruling out potentially curative tr...

Eligibility Criteria

Inclusion Criteria:

  • 50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
  • Haemoglobin A1c (HbA1c) ≥ 48 or 6.5% and/or confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance)
  • Willing to provide up to 30 mL of blood for each study visit
  • Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated)
  • Understands the study process and is willing to take part in the study and sign the informed consent form

Exclusion Criteria:

  • Prior type I or type II DM diagnosis > 6 months
  • A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
  • Under investigation for pancreatic cancer / pancreatic cyst
  • Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months
  • Any invasive solid or haematological cancer in the past 3 years, including cancer recurrence after treatment in the last 3 years
  • Current chronic or acute oral or systemic steroid use within 3 months of initial HbA1c or diabetes diagnosis (estimate rather than accurate)
  • Blood transfusion within 1 month
  • Solid organ transplant recipient
  • Currently pregnant
  • Needing dialysis

Key Trial Info

Start Date :

May 21 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2029

Estimated Enrollment :

15000 Patients enrolled

Trial Details

Trial ID

NCT06803771

Start Date

May 21 2025

End Date

February 1 2029

Last Update

March 23 2026

Active Locations (31)

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Page 1 of 8 (31 locations)

1

Ashfields Primary Care Centre

Sandbach, Cheshire, United Kingdom, CW11 1EQ

2

Maidstone and Tunbridge Wells NHS Trust

Maidstone, Kent, United Kingdom, ME16 9QQ

3

Balance Street Health Centre

Uttoxeter, Kent, United Kingdom, ST14 8JG

4

Forest Medical Group

Leicester, Leicester Forest East, United Kingdom, LE3 3LW