Screening newly diagnosed diabetics for pancreatic cancer using a blood and urine test

Not Applicable

• Conditions: Pancreatic cancer, diabetes; Cancer; Malignant neoplasm of pancreas, diabetes mellitus

• Registration Number: ISRCTN85533678
• Lead Sponsor: Spital Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-01
• Last Update Posted: 18 September 2023
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1000

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>Updated 28/05/2020: follow-up changed from 2 years to 3 years.

Secondary Outcome Measures

Name	Time	Method
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<br>1.1. The receiver operating characteristic (ROC)<br>1.2. Area under the curve (AUC)<br>1.3. Sensitivity<br>1.4. Specificity<br>1.5. Predictive values<br>1.6. Probability values<br>As a gold standard, we use a CT to confirm positive screening tests, and a 3-year follow-up to confirm negative tests<br>2. Mean survival of PDAC patients who were diagnosed at the screening, assessed using Kaplan-Meier curves, assessed at the 3-year follow-up<br>3. Stage of the PDAC at diagnosis, assessed using the numbers of participants with each stage of PDAC<br><br>Updated 28/05/2020: follow-up changed from 2 years to 3 years.