Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers

Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers (UroPanc)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04449406

Acronym

UroPanc

Enrollment

3500

Registered

2020-06-26

Start date

2020-01-01

Completion date

2026-08-31

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Biomarker, PDAC, Pancreatic cancer, CA19-9, Urine

Brief summary

Urine and blood samples are being collected from patients with and without diseases of the pancreas. These samples will be tested with the aim of developing an accurate way of diagnosing diseases of the pancreas using the results.

Detailed description

The main aim of this research study is to establish the accuracy of a urinary biomarker panel (LYVE1, REG1B, TFF1), and affiliated PancRISK score alone or in combination with plasma CA19-9 for early detection of pancreatic ductal adenocarcinoma (PDAC). Samples will be collected from symptomatic individuals with suspected pancreatic cancer, and asymptomatic subjects at risk of developing PDAC. The results of urine biomarker and CA19-9 analysis carried out on these samples will be compared to the imaging and, where available, histopathology data, which will inform the development of a predictive model to detect PDAC earlier.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

(Symptomatic patients): * Able and willing to give informed consent * ≥18 years old * Suspected pancreatic diseases with symptoms including, but not limited to, diarrhoea, back pain, abdominal pain, nausea, vomiting, constipation or new onset diabetes

Exclusion criteria

(Symptomatic patients): * Current or prior treatment (chemotherapy, radiotherapy, surgical resection, biological therapy, and immunotherapy) for any malignancy other than basal cell carcinoma within 5 years of enrolment. Asymptomatic participants will be identified through the EUROPAC registry and will fulfil EUROPAC's eligibility criteria.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of biomarker panel and affiliated risk score	Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)	Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).

Secondary

Measure	Time frame	Description
Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result	Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)	Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
Economic and social impact of using biomarker panel for PDAC testing	Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)	Stakeholder and health economics analyses of the inclusion of the urine test into the existing diagnostic and surveillance pathways for PDAC.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORTatjana Crnogorac-Jurcevic, MD, PhD

Queen Mary University of London

Outcome results