Pancreatic cancer, diabetes Cancer Malignant neoplasm of pancreas, diabetes mellitus
Conditions
Interventions
Current interventions as of 28/05/2020:
Participants' personal information and medical history will be collected, along with blood and urine samples. Measurements of HbA1c and CA-19-9 will be taken fr
Sponsors
Spital Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Either: Newly diagnosed diabetes mellitus, defined as HbA1c >6.5% (diagnosed within 1 month before inclusion) Or: Newly diagnosed prediabetes, defined as HbA1c > 6 % at two occasions with an interval of = 6 months (second measurement within the last month) Participants should also have one or more of the following risk factors of PDAC: 1. Aged 50 years or older 2. Smoking 3. Positive family history for PDAC 4. Status post gestational diabetes 5. Chronic pancreatitis
Exclusion criteria
Exclusion criteria: 1. Inability to follow the procedures of the study or missing ability to provide informed consent (e.g. due to age, language, psychological factors, dementia, etc) 2. Known PDAC 3. Other preexisting gastrointestinal cancers 4. Pregnancy 5. Known severe renal insufficency (Clearance <30 ml) 6. Aged below 18 years Updated 28/05/2020: 6. Aged below 40 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Screening prevalence of PDAC in both screened populations, determined as the proportion of screened patients who have a positive screening test for PDAC with a confirmed CT diagnosis, or diagnosed during the 3-year follow-up Updated 28/05/2020: follow-up changed from 2 years to 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic performance of the urine 3-biomarker panel with serum CA19-9, assessed at predefined thresholds using the numbers of true positives, false positives, true negatives and false negatives from this test 1.1. The receiver operating characteristic (ROC) 1.2. Area under the curve (AUC) 1.3. Sensitivity 1.4. Specificity 1.5. Predictive values 1.6. Probability values As a gold standard, we use a CT to confirm positive screening tests, and a 3-year follow-up to confirm negative tests 2. Mean survival of PDAC patients who were diagnosed at the screening, assessed using Kaplan-Meier curves, assessed at the 3-year follow-up 3. Stage of the PDAC at diagnosis, assessed using the numbers of participants with each stage of PDAC Updated 28/05/2020: follow-up changed from 2 years to 3 years. | — |
Countries
Switzerland
Outcome results
None listed