Main
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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:
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ISRCTN |
Last refreshed on:
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18 September 2023 |
Main ID: |
ISRCTN85533678 |
Date of registration:
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01/10/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Screening newly diagnosed diabetics for pancreatic cancer using a blood and urine test
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Scientific title:
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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:
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01/06/2019 |
Target sample size:
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1000 |
Recruitment status: |
Ongoing |
URL:
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https://www.isrctn.com/ISRCTN85533678 |
Study type:
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Observational |
Study design:
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Observational exploratory regional single-centre cohort study (Screening)
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Phase:
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Not Applicable
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Claudia
Mellenthin |
Address:
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Chemin de Pennsionat 2-4
1700
Freiburg
Switzerland |
Telephone:
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+41 (0)797543292 |
Email:
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dr.mellenthin@hin.ch |
Affiliation:
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Name:
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Address:
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Telephone:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Pancreatic cancer, diabetes Cancer Malignant neoplasm of pancreas, diabetes mellitus
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Spital Freiburg
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Ethics approval will be sought prior to recruitment
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Results
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Results available:
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Date Posted:
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Date Completed:
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30/12/2030 |
URL:
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