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

N/AActive Not RecruitingNCT04449406

Queen Mary University of London3,500 enrolled

Overview

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.

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

3,500

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

EUROPAC study, University of Liverpool

Liverpool, United Kingdom

ADEPTS study, University College London

London, United Kingdom

Imperial College London

London, United Kingdom

Royal London Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)

Secondary Outcomes

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).

Time frame: 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.

Time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)

Data from ClinicalTrials.gov

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