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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Ductal Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals at risk of developing PDAC<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of biomarker panel and affiliated risk score | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Biomarker, PDAC, CA19-9, Urine