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ISRCTN85533678

Screening newly diagnosed diabetics and prediabetics using a blood and urine test

Data source: WHO (Imported from 03.05.2024)
Changed: Jun 2, 2019, 2:00 AM
Disease category:

Health conditions (Data source: WHO)

Pancreatic cancer Diabetes Prediabetes
Cancer
Malignant neoplasm of pancreas Diabetes mellitus Prediabetes

Interventions (Data source: WHO)

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.

Inclusion/Exclusion Criteria (Data source: WHO)

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

Further information on the trial in WHO primary registry

http://isrctn.com/ISRCTN85533678

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN85533678
Further information on trial

Date trial registered

Oct 1, 2018

Incorporation of the first participant

Jun 1, 2019

Recruitment status

Ongoing

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Observational

Design of the trial (Data source: WHO)

Observational exploratory regional single-centre cohort study
(Screening)

Phase (Data source: WHO)

Not Applicable

Primary end point (Data source: WHO)

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.

Secundary end point (Data source: WHO)

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

Contact information (Data source: WHO)

Schweizer Pankreasstiftung

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Contact for scientific information (Data source: WHO)

Claudia
Mellenthin
Schänzlihalde 1
41797543292
dr.mellenthin@hin.ch

Further trial identification numbers

Secondary ID (Data source: WHO)

DOT PANC
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