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| Name | Class |
|---|---|
| University of Liverpool | OTHER |
| University College, London | OTHER |
| Imperial College London | OTHER |
| Pancreatic Cancer Research Fund |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals at risk of developing PDAC |
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). |
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| 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) |
| 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) |
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Inclusion criteria (Symptomatic patients):
Exclusion criteria (Symptomatic patients):
Asymptomatic participants will be identified through the EUROPAC registry and will fulfil EUROPAC's eligibility criteria.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Crnogorac-Jurcevic, MD, PhD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EUROPAC study, University of Liverpool | Liverpool | United Kingdom | ||||
| ADEPTS study, University College London |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33301466 | Background | Debernardi S, O'Brien H, Algahmdi AS, Malats N, Stewart GD, Pljesa-Ercegovac M, Costello E, Greenhalf W, Saad A, Roberts R, Ney A, Pereira SP, Kocher HM, Duffy S, Blyuss O, Crnogorac-Jurcevic T. A combination of urinary biomarker panel and PancRISK score for earlier detection of pancreatic cancer: A case-control study. PLoS Med. 2020 Dec 10;17(12):e1003489. doi: 10.1371/journal.pmed.1003489. eCollection 2020 Dec. | |
| 36093581 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| UNKNOWN |
| Ospedale San Raffaele | OTHER |
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Urine and blood samples
| 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) |
| London |
| United Kingdom |
| Imperial College London | London | United Kingdom |
| Royal London Hospital | London | United Kingdom |
| Background |
| Debernardi S, Blyuss O, Rycyk D, Srivastava K, Jeon CY, Cai H, Cai Q, Shu XO, Crnogorac-Jurcevic T. Urine biomarkers enable pancreatic cancer detection up to 2 years before diagnosis. Int J Cancer. 2023 Feb 15;152(4):769-780. doi: 10.1002/ijc.34287. Epub 2022 Sep 23. |
| 26240291 | Background | Radon TP, Massat NJ, Jones R, Alrawashdeh W, Dumartin L, Ennis D, Duffy SW, Kocher HM, Pereira SP, Guarner posthumous L, Murta-Nascimento C, Real FX, Malats N, Neoptolemos J, Costello E, Greenhalf W, Lemoine NR, Crnogorac-Jurcevic T. Identification of a Three-Biomarker Panel in Urine for Early Detection of Pancreatic Adenocarcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3512-21. doi: 10.1158/1078-0432.CCR-14-2467. |
| 31857725 | Background | Blyuss O, Zaikin A, Cherepanova V, Munblit D, Kiseleva EM, Prytomanova OM, Duffy SW, Crnogorac-Jurcevic T. Development of PancRISK, a urine biomarker-based risk score for stratified screening of pancreatic cancer patients. Br J Cancer. 2020 Mar;122(5):692-696. doi: 10.1038/s41416-019-0694-0. Epub 2019 Dec 20. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |