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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 18 September 2023
Main ID:  ISRCTN85533678
Date of registration: 01/10/2018
Prospective Registration: Yes
Primary sponsor: Spital Freiburg
Public title: Screening newly diagnosed diabetics for pancreatic cancer using a blood and urine test
Scientific title: Pancreatic Cancer Testing in Emerging Diabetes (PACTED) using a urine 3-biomarker panel (LYVE1, REG1B, TFF1) and Serum CA 19-9
Date of first enrolment: 01/06/2019
Target sample size: 1000
Recruitment status: Ongoing
URL:  https://www.isrctn.com/ISRCTN85533678
Study type:  Observational
Study design:  Observational exploratory regional single-centre cohort study (Screening)  
Phase:  Not Applicable
Countries of recruitment
Switzerland
Contacts
Name: Claudia    Mellenthin
Address:  Chemin de Pennsionat 2-4 1700 Freiburg Switzerland
Telephone: +41 (0)797543292
Email: dr.mellenthin@hin.ch
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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: 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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Pancreatic cancer, diabetes
Cancer
Malignant neoplasm of pancreas, diabetes mellitus
Intervention(s)
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 from the blood and urine samples, along with a 3-biomarker panel. In those who test positive for PDAC in these first tests, a contrasted abdominal MRI scan will be performed. Those testing negative from the biomarker test or MRI scan will have regular screening for PDAC every 3-6 months for 3 years by their family doctor.

Previous interventions:
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 from the blood and urine samples, along with a 3-biomarker panel. In those who test positive for PDAC in these first tests, serum creatinine will be measured to assess kidney function. If there is no contraindication (i.e. if kidney function is normal), a contrasted abdominal CT scan will be performed (in case of a contraindication (kidney failure), an MRI scan will be done instead). Those testing negative from the biomarker test or CT scan will have regular screening for PDAC every 3-6 months for 2 years by their family doctor.
Primary Outcome(s)
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 Outcome(s)
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.
Secondary ID(s)
Nil known
Source(s) of Monetary Support
Spital Freiburg
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Old ethics approval format; Ethics approval will be sought prior to recruitment
Results
Results available:
Date Posted:
Date Completed: 30/12/2030
URL:
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