Brief Summary

The main purpose of the study is to assess the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma (PDAC) the most common type of pancreatic cancer that accounts for approximately 90% of all pancreatic cancer cases.

The study aims to characterize the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma in patients with symptoms supporting a clinical suspicion of pancreatic cancer The Panuri test is intended for professional laboratory use for diagnostic purposes.

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention / Treatment

• Diagnostic Test: Panuri test

Primary Outcome Measures

• The primary objective of the study is to estimate Panuri performance for the detection of PDAC. (From enrollment up to 6 months)
  The primary analysis for sensitivity will be performed using data from the target and enriched arms. The primary analysis for specificity will be performed using data from the target arm only.

Countries

Hungary, Italy, Poland

Locations and Investigators

• Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház, Békéscsaba, Hungary (Not yet recruiting)
  • Márta Varga, MD (Principal Investigator)
• Pankreász Betegségek Intézete Semmelweis Egyetem, Budapest, Hungary (Not yet recruiting)
  • Tibor Csőszi, MD (Principal Investigator)
• Bács-Kiskun Vármegyei Oktatókórház, Kecskemét, Hungary (Not yet recruiting)
  • Péter Novák, MD (Principal Investigator)
• Csőszi Endoszkópos Kft., Kecskemét, Hungary (Recruiting)
  • Tibor Csőszi, MD (Principal Investigator)
• Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Dr. Bugyi István Szentesi Multidiszciplináris Centrum, Szentes, Hungary (Not yet recruiting)
  • László Nagy, MD (Principal Investigator)
• Gastroenterologia ed Endoscopia digestiva Ospedale "Morgagni - Pierantoni" di Forlì, Forlì, Italy (Not yet recruiting)
  • Carlo Fabbri, Professor, MD, PhD (Principal Investigator)
• Pancreas Translational and Clinical Center IRCCS Ospedale San Raffaele, Milan, Italy (Not yet recruiting)
  • Gabriele Capurso, Professor, MD, PhD (Principal Investigator)
• Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia (IEO), Milan, Italy (Not yet recruiting)
  • Lorenzo Gravaso, MD, PhD (Principal Investigator)
• SC Chirurgia Generale 1 Fondazione IRCCS Policlinico "San Matteo", Pavia, Italy (Not yet recruiting)
  • Lorenzo Cobianchi, Professor, MD, PhD (Principal Investigator)
• UOC Gastroenterologia Azienda Ospedaliero Universitaria Pisana, Pisa, Italy (Not yet recruiting)
  • Massimo Bellini, Professor, MD, PhD (Principal Investigator)
• Unità Operativa Complessa di Endoscopia Digestiva Chirurgica Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy (Not yet recruiting)
  • Cristiano Spada, Professor, MD, PhD (Principal Investigator)
• Unità Operativa di Chirurgia Pancreatica IRCCS Istituto Clinico Humanitas, Rozzano, Italy (Not yet recruiting)
  • Alessandro Zerbi, Professor, MD, PhD (Principal Investigator)
• Niepubliczny Zakład Opieki Zdrowotnej "Diagmed" J.Bajorek, N.Kopeć Spółka Jawna, Dąbrowa Tarnowska, Poland (Recruiting)
  • Mikołaj Turski, MD (Principal Investigator)
• SPZOZ Uniwersyteckie Centrum Kliniczne Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej, Gdansk, Poland (Not yet recruiting)
  • Kamil Drucis, MD, PhD (Principal Investigator)
• Przychodnia KOPERNIKA Sp. z o.o., Grudziądz, Poland (Recruiting)
  • Cezary Strugała, MD, PhD (Principal Investigator)
• Ośrodek Badań Klinicznych BD Research Sp. z o.o., Iława, Poland (Recruiting)
  • Jakub Baszczyński, MD (Principal Investigator)
• OŚRODEK MEDYCZNY "OSTEOMED" S.C. Mirosław Szlachcic, Ewa Szlachcic, Krakow, Poland (Active not recruiting)
• Comarch Healthcare S.A. Centrum Medyczne iMed24, Krakow, Poland (Not yet recruiting)
  • Paweł Potocki, MD, PhD (Principal Investigator)
• Salve Medica Sp. z o.o., Lodz, Poland (Recruiting)
  • Monika Kukulska, MD, PhD (Principal Investigator)
• Zanamed Medical Clinic Sp. z o.o., Lublin, Poland (Recruiting)
  • Michał Łoziński, MD (Principal Investigator)
• Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o., Malbork, Poland (Not yet recruiting)
  • Magdalena Wojanowska-Pindel, MD (Principal Investigator)
• Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o., Pleszew, Poland (Not yet recruiting)
  • Krzysztof Cieszyński, MD, PhD (Principal Investigator)
• Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie, Poznan, Poland (Active not recruiting)
• Uniwersytecki Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego PUM w Szczecinie, Szczecin, Poland (Active not recruiting)
• Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka Sp. z. o.o., Słupsk, Poland (Active not recruiting)
• Metabolica Sp. z o.o., Tarnów, Poland (Recruiting)
  • Robert Witek, MD (Principal Investigator)
• Onkomedica Sp. z o.o., Warsaw, Poland (Recruiting)
  • Paweł Morawski, MD (Principal Investigator)
• Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji, Warsaw, Poland (Active not recruiting)
• Wielospecjalistyczny Szpital Medicover, Warsaw, Poland (Not yet recruiting)
  • Marek Durlik, Professor, MD, PhD (Principal Investigator)
• Military Institute of Medicine - National Research Institute, Warsaw, Poland (Recruiting)
  • Department of Gastroenterology and Internal Medicine
  • Maciej Gonciarz, Professor, MD, PhD (Principal Investigator)
• Centrum Medyczne K2J2, Wołomin, Poland (Not yet recruiting)
  • Katarzyna Kamińska-Stachniak, MD, PhD (Principal Investigator)
• 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu, Wroclaw, Poland (Recruiting)
  • Mateusz Tabin, MD, PhD (Principal Investigator)