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

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT04449406
• Lead Sponsor: Queen Mary University of London

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (4)

ADEPTS study, University College London; 🇬🇧 London, United Kingdom

Royal London Hospital; 🇬🇧 London, United Kingdom

Imperial College London; 🇬🇧 London, United Kingdom

EUROPAC study, University of Liverpool; 🇬🇧 Liverpool, United Kingdom