Condition category
Cancer
Date applied
18/09/2018
Date assigned
01/10/2018
Last edited
07/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Type 2 diabetes is one of the most common diagnoses in Swiss family practices. The incidence of diabetes increases with age - by 75 years old, nearly 1/3 of the population has diabetes.

About 80% of pancreatic cancer patients have elevated blood sugar or diabetes. Newly discovered diabetes can be an early symptom of pancreatic cancer. Studies show that this patients already have elevated HbA1c (a marker of diabetes) levels up to 5 years prior to a pancreatic cancer diagnosis when compared to healthy individuals. This diabetes usually disappears after a successful operation on the pancreas.

Our hypothesis is that newly diagnosed diabetics or prediabetics (those who are not matching the criteria of diabetes, but have slighly elevated blood sugar) are a high-risk group for pancreatic cancer and eligible for screening. Our intention is to measure the frequency of pancreatic cancer in newly diagnosed diabetic and prediabetic patients, and to show that the combination of the urine 3-biomarker test (a new test) with serum CA 19-9 (an already used blood test) is a suitable screening method.

Who can participate?
People with newly diagnosed diabetes mellitus or newly diagnosed prediabetes. Participants should also have at least one of the risk factors for pancreatic cancer - aged over 50 years older, smokers, family history of pancreatic cancer, chronic pancreatitis or gestational diabetes.

What does the study involve?
Patient's height, weight, blood pressure and medical history will be taken and recorded by the family doctor, along with blood and urine samples. The blood and urine samples will then be used for screening for pancreatic cancer. If participants test positive for pancreatic cancer in these tests, they will have a test for kidney function. If kidney function is normal, a CT scan will be done to determine whether they have pancreatic cancer (if patients have kidney failure, they will have an MRI scan instead of a CT scan). Patients who are suspected of having pancreatic cancer after these scans will be referred to a specialist for treatment (treatment is not part of this study).

If participants test negative for pancreatic cancer in the initial tests or after the CT scan, they will be regularly screened for pancreatic cancer every 3-6 months for 2 years. If they do show symptoms of pancreatic cancer in these follow-up screenings, they will be referred to the Swiss Pancreas Center.

Where is the study run from?
Swiss Pancreas Center, Bern (Switzerland)

When is the study starting and how long is it expected to run for?
June 2016 to September 2023

Who is funding the study?
Schweizer Pankreasstiftung (Switzerland)

Who is the main contact?
Dr. med. Claudia Mellenthin
dr.mellenthin@hin.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudia Mellenthin

ORCID ID

Contact details

Schänzlihalde 1
Bern
3013
Switzerland
41797543292
dr.mellenthin@hin.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DOT PANC

Study information

Scientific title

Screening a cohort of newly diagnosed diabetics and prediabetics for pancreatic cancer using a urine 3-biomarker panel (LYVE1, REG1A, TFF1) and Serum CA 19-9

Acronym

DOT PANC

Study hypothesis

Our hypothesis is that newly diagnosed diabetics or prediabetics are a high-risk group for PDAC and eligible for screening. Our intention is therefore to measure the prevalence of PDAC in newly diagnosed diabetic and prediabetic patients, and to show that the combination of the urine 3-biomarker panel with serum CA 19-9 is a suitable screening method.

Ethics approval

Ethics approval will be sought prior to recruitment

Study design

Observational exploratory regional single-centre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Participant information sheet available – to be reviewed by ethics committee

Condition

Pancreatic cancer
Diabetes
Prediabetes

Intervention

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.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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 2-year follow-up.

Secondary outcome measures

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 2-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 2 year follow-up
3. Stage of the PDAC at diagnosis, assessed using the numbers of participants with each stage of PDAC

Overall trial start date

02/06/2016

Overall trial end date

01/09/2023

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant 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

Recruitment start date

01/06/2019

Recruitment end date

01/09/2021

Locations

Countries of recruitment

Switzerland

Trial participating centre

Schweizer Pankreaszentrum
Schänzlihalde 1
3013 Bern
3013
Switzerland

Sponsor information

Organisation

Schweizer Pankreaszentrum/ Prof. Z'graggen

Sponsor details

Schänzlihalde 1
Bern
3013
Switzerland
+41313353939
praxis.zgraggen@hirslanden.ch

Sponsor type

Hospital/treatment centre

Website

https://www.pancreas.ch

Funders

Funder type

Hospital/treatment centre

Funder name

Schweizer Pankreasstiftung

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish our data on the screening results as soon as the 2-year follow up of the last patient is terminated and data analysis is completed. Publications will follow the standards of STARD37 and STROBE41, to ascertain high quality reporting. Our secondary endpoint of survival will take longer to assess and will therefore be published later.

IPD sharing statement:
Data will only be shared anonymized and after we have been assured of the adequate data protection standards of the interested parties, if their intent is relevant for the goal of developing a screening program and if the reputation of the requesting research team is acceptable.

Intention to publish date

01/03/2024

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/05/2019: The contact details were updated.