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ISRCTN85533678

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

Datenbasis: WHO (Import vom 23.06.2019)
Geändert: 02.06.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

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

Interventions (Datenquelle: 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 (Datenquelle: 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

Weitere Angaben zur Studie im WHO-Primärregister

http://isrctn.com/ISRCTN85533678

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN85533678

Weitere Informationen zur Studie

Registrationsdatum der Studie

01.10.2018

Einschluss der ersten teilnehmenden Person

01.06.2019

Rekrutierungsstatus

Ongoing

Wissenschaftlicher Titel (Datenquelle: 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

Studientyp (Datenquelle: WHO)

Observational

Design der Studie (Datenquelle: WHO)


Observational exploratory regional single-centre cohort study
(Screening)

Phase (Datenquelle: WHO)

Not Applicable

Primäre Endpunkte (Datenquelle: 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.

Sekundäre Endpunkte (Datenquelle: 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

Kontakt für Auskünfte (Datenquelle: WHO)

Schweizer Pankreasstiftung

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

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

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Schweizer Pankreaszentrum/ Prof. Z'graggen

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

DOT PANC