Torna alla panoramica
ISRCTN85533678

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

Base di dati: WHO (Importata da 03.05.2024)
Cambiato: 2 giu 2019, 02:00
Categoria di malattie:

Health conditions (Fonte di dati: WHO)

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

Interventions (Fonte di dati: 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 (Fonte di dati: 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

Altri dati sulla sperimentazione nel registro primario dell’OMS

http://isrctn.com/ISRCTN85533678

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN85533678
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

1 ott 2018

Inserimento del primo partecipante

1 giu 2019

Stato di reclutamento

Ongoing

Titolo scientifico (Fonte di dati: 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

Tipo di sperimentazione (Fonte di dati: WHO)

Observational

Disegno della sperimentazione (Fonte di dati: WHO)

Observational exploratory regional single-centre cohort study
(Screening)

Fase (Fonte di dati: WHO)

Not Applicable

Punti finali primari (Fonte di dati: 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.

Punti finali secondari (Fonte di dati: 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

Contatto per informazioni (Fonte di dati: WHO)

Schweizer Pankreasstiftung

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Paesi di esecuzione (Fonte di dati: WHO)

Switzerland

Contatto per maggiori informazioni sulla sperimentazione

Contatto per informazioni scientifiche (Fonte di dati: WHO)

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

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

DOT PANC
Torna alla panoramica