Clinical trial · Interventional
Surveillance of Pancreatic Health After Diabetes Diagnosis
An Interventional Study to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Participants With Newly Diagnosed Diabetes Mellitus or Newly Elevated HbA1c
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus | — | UNRESOLVED | — |
| Pancreatic Cancer, Adult | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avantect Pancreatic Cancer Test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Participants will have their blood samples tested on the Avantect test within prioritised timeframe. The "detected" Avantect test results will be shared with the participants and their General Practitioners (GPs) to allow for further MRI or CT investigations by the local clinical team.
- interventionNames
- Device: Avantect Pancreatic Cancer Test
Primary outcomes (2)
- measure
- Sensitivity of the Avantect test
- timeFrame
- The final analysis will be carried out after 3-year follow up data has been collected for all 5,000 participants.
- description
- The proportion of individuals with one or more Avantect "detected" test result who have pancreatic cancer diagnosed via imaging in relation to all individuals in the study who had pancreatic cancer diagnosed.
- measure
- Specificity of the Avantect test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available