Panuri Performance Study

July 21, 2026 updated by: Urteste S.A

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary, 1083
        • Not yet recruiting
        • Pankreász Betegségek Intézete Semmelweis Egyetem
        • Principal Investigator:
          • Tibor Csőszi, MD
      • Békéscsaba, Hungary, 5600
        • Not yet recruiting
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
        • Principal Investigator:
          • Márta Varga, MD
      • Kecskemét, Hungary, 6000
        • Not yet recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz
        • Principal Investigator:
          • Péter Novák, MD
      • Kecskemét, Hungary, 6000
        • Recruiting
        • Csőszi Endoszkópos Kft.
        • Principal Investigator:
          • Tibor Csőszi, MD
      • Szentes, Hungary, 6600
        • Not yet recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Dr. Bugyi István Szentesi Multidiszciplináris Centrum
        • Principal Investigator:
          • László Nagy, MD
  • Italy
      • Forlì, Italy, 47121
        • Not yet recruiting
        • Gastroenterologia ed Endoscopia digestiva Ospedale "Morgagni - Pierantoni" di Forlì
        • Principal Investigator:
          • Carlo Fabbri, Professor, MD, PhD
      • Milan, Italy, 20132
        • Not yet recruiting
        • Pancreas Translational and Clinical Center IRCCS Ospedale San Raffaele
        • Principal Investigator:
          • Gabriele Capurso, Professor, MD, PhD
      • Milan, Italy, 20141
        • Not yet recruiting
        • Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia (IEO)
        • Principal Investigator:
          • Lorenzo Gravaso, MD, PhD
      • Pavia, Italy, 27100
        • Not yet recruiting
        • SC Chirurgia Generale 1 Fondazione IRCCS Policlinico "San Matteo"
        • Principal Investigator:
          • Lorenzo Cobianchi, Professor, MD, PhD
      • Pisa, Italy, 56124
        • Not yet recruiting
        • UOC Gastroenterologia Azienda Ospedaliero Universitaria Pisana
        • Principal Investigator:
          • Massimo Bellini, Professor, MD, PhD
      • Roma, Italy, 00168
        • Not yet recruiting
        • Unità Operativa Complessa di Endoscopia Digestiva Chirurgica Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Principal Investigator:
          • Cristiano Spada, Professor, MD, PhD
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Unità Operativa di Chirurgia Pancreatica IRCCS Istituto Clinico Humanitas
        • Principal Investigator:
          • Alessandro Zerbi, Professor, MD, PhD
  • Poland
      • Dąbrowa Tarnowska, Poland, 33-200
        • Recruiting
        • Niepubliczny Zakład Opieki Zdrowotnej "Diagmed" J.Bajorek, N.Kopeć Spółka Jawna
        • Principal Investigator:
          • Mikołaj Turski, MD
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • SPZOZ Uniwersyteckie Centrum Kliniczne Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej
        • Principal Investigator:
          • Kamil Drucis, MD, PhD
      • Grudziądz, Poland, 86-300
        • Recruiting
        • Przychodnia KOPERNIKA Sp. z o.o.
        • Principal Investigator:
          • Cezary Strugała, MD, PhD
      • Iława, Poland, 14-200
        • Recruiting
        • Ośrodek Badań Klinicznych BD Research Sp. z o.o.
        • Principal Investigator:
          • Jakub Baszczyński, MD
      • Krakow, Poland, 30-074
        • Active, not recruiting
        • OŚRODEK MEDYCZNY "OSTEOMED" S.C. Mirosław Szlachcic, Ewa Szlachcic
      • Krakow, Poland, 31-864
        • Not yet recruiting
        • Comarch Healthcare S.A. Centrum Medyczne iMed24
        • Principal Investigator:
          • Paweł Potocki, MD, PhD
      • Lodz, Poland, 91-211
        • Recruiting
        • Salve Medica Sp. z o.o.
        • Principal Investigator:
          • Monika Kukulska, MD, PhD
      • Lublin, Poland, 20-601
        • Recruiting
        • Zanamed Medical Clinic Sp. z o.o.
        • Principal Investigator:
          • Michał Łoziński, MD
      • Malbork, Poland, 82-200
        • Not yet recruiting
        • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
        • Principal Investigator:
          • Magdalena Wojanowska-Pindel, MD
      • Pleszew, Poland, 63-300
        • Not yet recruiting
        • Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o.
        • Principal Investigator:
          • Krzysztof Cieszyński, MD, PhD
      • Poznan, Poland, 61-866
        • Active, not recruiting
        • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie
      • Szczecin, Poland, 71-252
        • Active, not recruiting
        • Uniwersytecki Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego PUM w Szczecinie
      • Słupsk, Poland, 76-200
        • Active, not recruiting
        • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka Sp. z. o.o.
      • Tarnów, Poland, 33-100
        • Recruiting
        • Metabolica Sp. z o.o.
        • Principal Investigator:
          • Robert Witek, MD
      • Warsaw, Poland, 04-141
        • Recruiting
        • 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
        • Active, not recruiting
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
      • Warsaw, Poland, 01-934
        • Recruiting
        • Onkomedica Sp. z o.o.
        • Principal Investigator:
          • Paweł Morawski, MD
      • Warsaw, Poland, 02-972
        • Not yet recruiting
        • Wielospecjalistyczny Szpital Medicover
        • Principal Investigator:
          • Marek Durlik, Professor, MD, PhD
      • Wołomin, Poland, 05-200
        • Not yet recruiting
        • Centrum Medyczne K2J2
        • Principal Investigator:
          • Katarzyna Kamińska-Stachniak, MD, PhD
      • Wroclaw, Poland, 50-981
        • Recruiting
        • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu
        • Principal Investigator:
          • Mateusz Tabin, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 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.
From enrollment up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urteste S.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 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)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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