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NCT06803771
Surveillance of Pancreatic Health After Diabetes Diagnosis
Conditions: Diabetes Mellitus, Pancreatic Cancer, Adult
Sex: All
Ages: 50 Years – 84 Years
Healthy volunteers: No
Phase: NA
Enrollment: 5000
Sponsor: University Hospital Southampton NHS Foundation Trust
Location: Ashfields Primary Care Centre Sandbach Cheshire
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 or with elevated sugar levels within the last 200 days.
Participants will:
* attend 3 study visits over 12 months time
* provide a blood sample at each study visit
* complete an anxiety questionnaire at each visit.
Eligibility Criteria
Inclusion Criteria:
* 50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
* Confirmed type 2 DM diagnosis established within the last 200 days or an initial elevated HbA1c ≥ 48 mmol/mol or 6.5% obtained within the last 200 days. This includes people who have a first elevated HbA1c (≥ 48 mmol/mol or 6.5%) within the last 200 days, even if subsequent HbAc1 measurements return to the the normal range.
* Willing to provide up to 30 mL of blood for each study visit
* Willing and eligible to undergo MRI or CT scan
* 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 or an initial HbA1c ≥ 48 mmol/mol or 6.5% obtained prior to the 200-day inclusion window, except gestational elevated HbA1c.
* A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
* Under investigation for or confirmed pancreatic cancer
* Under investigation/surveillance for 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
* BMI \> 40 at the time of consent
* Blood transfusion within 1 month
* Solid organ transplant recipient
* Currently pregnant
* Needing dialysis
Source: ClinicalTrials.gov (NCT06803771). StuddyBuddy aggregates publicly available trial information.