Clinical trial NCT04449406: Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers
Official title: Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers (UroPanc)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Biomarker
PDAC
Pancreatic cancer
CA19-9
Urine
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University of Liverpool
name: University College, London
name: Imperial College London
name: Pancreatic Cancer Research Fund
name: Ospedale San Raffaele
First posted: 2020-06-26
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of biomarker panel and affiliated risk score
timeFrame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Secondary outcomes:
measure: Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result
timeFrame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
measure: Economic and social impact of using biomarker panel for PDAC testing
timeFrame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: EUROPAC study, University of Liverpool
city: London
country: United Kingdom
facility: ADEPTS study, University College London
city: London
country: United Kingdom
facility: Imperial College London
city: London
country: United Kingdom
facility: Royal London Hospital
Study officials:
affiliation: Queen Mary University of London
name: Tatjana Crnogorac-Jurcevic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.