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

August 10, 2022 updated by: Queen Mary University of London

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom
        • Active, not recruiting
        • EUROPAC study, University of Liverpool
      • London, United Kingdom
        • Active, not recruiting
        • ADEPTS study, University College London
      • London, United Kingdom
        • Active, not recruiting
        • Imperial College London
      • London, United Kingdom
        • Recruiting
        • Royal London Hospital
        • Contact:
        • Principal Investigator:
          • Patrick Wilson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples from symptomatic and asymptomatic individuals at risk of PDAC will be provided to the UroPanc team by collaborating centres via dedicated tissue banks/registries already in place at UCL (ADEPTS) and the University of Liverpool (EUROPAC).

Symptomatic individuals at risk which are being referred to specialist care by their general practitioners (GPs) will be recruited to participate in UroPanc when attending clinics (gastroenterology clinics, endoscopy units and Multidisciplinary Diagnostic Centres (MDCs)) at a participating study site.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Individuals at risk of developing PDAC
  • Symptomatic participants (via direct recruitment to UroPanc and via study/tissue bank(s) i.e. UCL ADEPTs study)
  • Asymptomatic participants (via study/tissue bank(s) i.e. University of Liverpool EUROPAC registry)

Medical history, demographic information and concomitant medications information will be collected at baseline, together with blood and urine samples. Urinary biomarkers and plasma CA19-9 will be measured and the results compared with imaging data (and pathology, if it becomes available).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
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.
Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Imperial College London
University College, London
University of Liverpool
Pancreatic Cancer Research Fund

Investigators

  • Principal Investigator: Tatjana Crnogorac-Jurcevic, MD, PhD, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012335QM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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