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ISRCTN85533678

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

Base de données : WHO (Importation du 03.05.2024)
Modifié: 2 juin 2019 à 02:00
Catégorie de maladie:

Health conditions (Source de données: WHO)

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

Interventions (Source de données: 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 (Source de données: 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

Plus de données sur l’étude tirée du registre primaire de l’OMS

http://isrctn.com/ISRCTN85533678

Plus de données sur l’étude tirée de la base de données de l’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN85533678
Plus d’informations sur l’étude

Date d’enregistrement de l’étude

1 oct. 2018

Intégration du premier participant

1 juin 2019

Statut de recrutement

Ongoing

Titre scientifique (Source de données: 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 d’étude (Source de données: WHO)

Observational

Conception de l’étude (Source de données: WHO)

Observational exploratory regional single-centre cohort study
(Screening)

Phase (Source de données: WHO)

Not Applicable

Points finaux primaires (Source de données: 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.

Points finaux secondaires (Source de données: 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 pour informations (Source de données: WHO)

Schweizer Pankreasstiftung

Résultats de l’étude (Source de données: WHO)

Résumé des résultats

pas encore d’informations disponibles

Lien vers les résultats dans le registre primaire

pas encore d’informations disponibles

Informations sur la disponibilité des données individuelles des participants

pas encore d’informations disponibles

Lieux de réalisation des études

Pays où sont réalisées les études (Source de données: WHO)

Switzerland

Contact pour plus d’informations sur l’étude

Contact pour des informations scientifiques (Source de données: WHO)

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

Plus de numéros d’identification d’étude

Secondary ID (Source de données: WHO)

DOT PANC
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