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NCT Number: NCT04449406

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EUROPAC study, University of Liverpool, Liverpool, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Accuracy of biomarker panel and affiliated risk score

    Time frame: 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 outcomes

  1. Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result

    Time frame: 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).

  2. Economic and social impact of using biomarker panel for PDAC testing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Imperial College London
  • Ospedale San Raffaele
  • Pancreatic Cancer Research Fund
  • University College, London
  • University of Liverpool

Registry information

Official study title

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

Acronym: UroPanc

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2020
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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