Panuri Performance Study

Evaluation of the Performance of Panuri - Test for Detection of Pancreatic Ductal Adenocarcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Intervention / Treatment: Diagnostic test: Panuri test

Detailed Description

This is a prospective, multi-site, enriched, observational, non-interventional clinical study to characterize the performance of Panuri for the detection of pancreatic ductal adenocarcinoma (PDAC) in symptomatic patients. The study is enriched for patients with pancreatic cancer.

Panuri is a qualitative, chromogenic, automated in vitro diagnostic assay designed to detect, in human urine samples, the proteolytic enzymes activity associated with pancreatic ductal adenocarcinoma. The Panuri test is indicated in adult patients with symptoms supporting a clinical suspicion of pancreatic cancer at initial presentation. The Panuri test is to be used in conjunction with the initial workup to help physicians evaluate whether further diagnostic imaging (e.g., CT/MRI) is required. All participants will have their reference standard diagnosis identified through review of electronic health records (EHR).

Participants and physicians will remain blinded to the results of Panuri testing.

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Karolina Stanny; Phone Number: +48 572 722 750; Email: karolina.stanny@urteste.eu
• Study Contact Backup: Name: Aurevia Poland Sp. z o.o.; Email: office@aurevia.com

Study Locations

• Hungary
  • Budapest, Hungary, 1083
    • Pankreász Betegségek Intézete Semmelweis Egyetem
    • Principal Investigator: Tibor Csőszi, MD
  • Békéscsaba, Hungary, 5600
    • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
    • Principal Investigator: Márta Varga, MD
  • Kecskemét, Hungary, 6000
    • Bács-Kiskun Vármegyei Oktatókórház
    • Principal Investigator: Péter Novák, MD
  • Kecskemét, Hungary, 6000
    • Csőszi Endoszkópos Kft.
    • Principal Investigator: Tibor Csőszi, MD
  • Szentes, Hungary, 6600
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Dr. Bugyi István Szentesi Multidiszciplináris Centrum
    • Principal Investigator: László Nagy, MD
• Italy
  • Forlì, Italy, 47121
    • Gastroenterologia ed Endoscopia digestiva Ospedale "Morgagni - Pierantoni" di Forlì
    • Principal Investigator: Carlo Fabbri, Professor, MD, PhD
  • Milan, Italy, 20132
    • Pancreas Translational and Clinical Center IRCCS Ospedale San Raffaele
    • Principal Investigator: Gabriele Capurso, Professor, MD, PhD
  • Milan, Italy, 20141
    • Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia (IEO)
    • Principal Investigator: Lorenzo Gravaso, MD, PhD
  • Pavia, Italy, 27100
    • SC Chirurgia Generale 1 Fondazione IRCCS Policlinico "San Matteo"
    • Principal Investigator: Lorenzo Cobianchi, Professor, MD, PhD
  • Pisa, Italy, 56124
    • UOC Gastroenterologia Azienda Ospedaliero Universitaria Pisana
    • Principal Investigator: Massimo Bellini, Professor, MD, PhD
  • Roma, Italy, 00168
    • Unità Operativa Complessa di Endoscopia Digestiva Chirurgica Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Principal Investigator: Cristiano Spada, Professor, MD, PhD
  • Rozzano, Italy, 20089
    • Unità Operativa di Chirurgia Pancreatica IRCCS Istituto Clinico Humanitas
    • Principal Investigator: Alessandro Zerbi, Professor, MD, PhD
• Poland
  • Dąbrowa Tarnowska, Poland, 33-200
    • Niepubliczny Zakład Opieki Zdrowotnej "Diagmed" J.Bajorek, N.Kopeć Spółka Jawna
    • Principal Investigator: Mikołaj Turski, MD
  • Gdansk, Poland, 80-214
    • SPZOZ Uniwersyteckie Centrum Kliniczne Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej
    • Principal Investigator: Kamil Drucis, MD, PhD
  • Grudziądz, Poland, 86-300
    • Przychodnia KOPERNIKA Sp. z o.o.
    • Principal Investigator: Cezary Strugała, MD, PhD
  • Iława, Poland, 14-200
    • Ośrodek Badań Klinicznych BD Research Sp. z o.o.
    • Principal Investigator: Jakub Baszczyński, MD
  • Krakow, Poland, 30-074
    • OŚRODEK MEDYCZNY "OSTEOMED" S.C. Mirosław Szlachcic, Ewa Szlachcic
    • Principal Investigator: Mirosław Szlachcic, MD, PhD
  • Lodz, Poland, 91-211
    • Salve Medica Sp. z o.o.
    • Principal Investigator: Monika Kukulska, MD, PhD
  • Lublin, Poland, 20-601
    • ZANA-MED MEDICAL GROUP Sp. z o.o.
    • Principal Investigator: Michał Łoziński, MD
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
    • Principal Investigator: Karol Połom, Professor, MD, PhD
  • Szczecin, Poland, 71-252
    • Uniwersytecki Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego PUM w Szczecinie
    • Principal Investigator: Krzysztof Dąbkowski, MD, PhD
  • Słupsk, Poland, 76-200
    • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka Sp. z. o.o.
    • Principal Investigator: Wojciech Rogowski, Professor, MD, PhD
  • Tarnów, Poland, 33-100
    • Metabolica Sp. z o.o.
    • Principal Investigator: Robert Witek, MD
  • Warsaw, Poland, 04-141
    • Military Institute of Medicine - National Research Institute
    • Contact: Department of Gastroenterology and Internal Medicine; Phone Number: +48 261 817 599; Email: dyrekcja@wim.mil.pl
    • Principal Investigator: Maciej Gonciarz, Professor, MD, PhD
  • Warsaw, Poland, 02-507
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
    • Principal Investigator: Marta Matejak - Górska, MD
  • Warsaw, Poland, 01-934
    • Onkomedica Sp. z o.o.
    • Principal Investigator: Paweł Morawski, MD
  • Wołomin, Poland, 05-200
    • Centrum Medyczne K2J2
    • Principal Investigator: Katarzyna Kamińska-Stachniak, MD, PhD
  • Wroclaw, Poland, 50-981
    • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
    • Principal Investigator: Mateusz Tabin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients presenting to healthcare providers with symptoms supporting a clinical suspicion of pancreatic cancer. The enriched arm will recruit sequential patients scheduled for pancreatic histopathological assessment.

Description

Inclusion Criteria:

• Arm 1 (Target Arm):

  • Adults 18 years and older
  • Presenting with symptoms supporting a clinical suspicion for pancreatic cancer by the healthcare provider, including but not limited to jaundice, abdominal or back pain, fatty stools, unexplained weight loss, loss of appetite, chronic fatigue, nausea, vomiting, indigestion, bloating, gas, diarrhea, constipation, itching, dark urine, fever, and swelling of the legs.

• Arm 2 (Enriched Arm):

  • Adults 18 years and older
  • Scheduled for a procedure involving pancreatic histopathological assessment due to suspicion of pancreatic cancer.

Exclusion Criteria:

• For subjects in the enriched arm, imaging results are highly suspicious for non-PDAC pancreatic cancer.
• Patients enrolled in a pancreatic cancer screening program.
• Prior diagnosis of pancreas malignancy, including pathological diagnoses and suspicion of pancreatic cancer based on clinical, histopathological or radiological results. Exceptions include: pancreatic intraepithelial neoplasia (PanIN), intraductal papillary mucinous neoplasms (IPMN), mucinous cystadenoma of the pancreas (MCN), serous cystadenomas (SCN) or other benign pancreatic lesions and cystic lesions without features suggestive of malignancy.
• History of pancreatic resection
• Presenting with concurrent symptoms or suspicion of urinary tract infection Diagnosis of any urinary tract infection within the last 30 days, except for cases that have been resolved with antibiotics discontinued at least 14 days prior to enrollment
• Diagnosed with stage 3b to 5 chronic kidney diseases (CDK3b-CDK5), acute kidney disease in last 3 months, nephrotic syndrome in the last 6 months, or other kidney diseases associated with proteinuria
• Diagnosed with any conditions that increase bilirubin levels within the last 6 months
• Self-reported or documented elevated blood bilirubin levels within the past 3 months, defined as exceeding 1.5 times the upper limit of normal specific to the test laboratory
• Diagnosis of any cancer within the past 5 years
• Chemotherapy or anti-neoplastic therapy within the last 5 years
• Any medical or psychological conditions that preclude compliance with study procedures.
• Patients without any clinical signs or symptoms of pancreatic cancer
• Inability to provide written informed consent.
• Pregnant or breastfeeding women
• Current participation in another drug or device study or planned participation prior to completion of sample collection procedures (i.e., approximately 1.5 months)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1 (Target Arm); patients presenting to healthcare providers with symptoms supporting a clinical suspicion of pancreatic cancer	Diagnostic test: Panuri test; In vitro diagnostic assay designed to detect, in human urine samples pancreatic ductal adenocarcinoma
Arm 2 (Enriched Arm); patients scheduled for a procedure involving pancreatic cancer histopathological assessment	Diagnostic test: Panuri test; In vitro diagnostic assay designed to detect, in human urine samples pancreatic ductal adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective of the study is to estimate Panuri performance for the detection of PDAC.	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.	From enrollment up to 6 months

Collaborators and Investigators

• Sponsor: Urteste S.A

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: clinical performance study; in vitro diagnostic assay
• Other Study ID Numbers: UR-CPS-01-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No