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

Pancreatic Ductal Adenocarcinoma Clinical Trial

— UroPanc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449406
• Other study ID #: 012335QM
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 2024

Study information

• Verified date: August 2022
• Source: Queen Mary University of London
• Contact: UroPanc Coordinator
• Phone: 020 7882 8497
• Email: bci-uropanc[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (5)

Lead Sponsor	Collaborator
Queen Mary University of London	Imperial College London, Pancreatic Cancer Research Fund, University College, London, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)