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Pancreatic Ductal Adenocarcinoma (PDAC)NCT07587866

Panuri Performance Study

An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Urteste S.A at 32 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
Panuri test
How many people
1,100 participants
Where
32 sitesin 3 countries
Study dates
10 Jun 2026to Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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)

Trial locations and contacts

32 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Karolina Stanny contact

+48 572 722 750

karolina.stanny@urteste.eu

Aurevia Poland Sp. z o.o. contact

office@aurevia.com

32 sites in 3 countries

Poland20 sites, 15 recruiting

  • Niepubliczny Zakład Opieki Zdrowotnej "Diagmed" J.Bajorek, N.Kopeć Spółka Jawna

    Dąbrowa Tarnowska, 33-200

    Mikołaj Turski, MD

    Recruiting

  • SPZOZ Uniwersyteckie Centrum Kliniczne Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej

    Gdansk, 80-214

    Kamil Drucis, MD, PhD

    Not yet recruiting

  • Przychodnia KOPERNIKA Sp. z o.o.

    Grudziądz, 86-300

    Cezary Strugała, MD, PhD

    Recruiting

  • Ośrodek Badań Klinicznych BD Research Sp. z o.o.

    Iława, 14-200

    Jakub Baszczyński, MD

    Recruiting

  • OŚRODEK MEDYCZNY "OSTEOMED" S.C. Mirosław Szlachcic, Ewa Szlachcic

    Krakow, 30-074

    Active, not recruiting

  • Comarch Healthcare S.A. Centrum Medyczne iMed24

    Krakow, 31-864

    Paweł Potocki, MD, PhD

    Not yet recruiting

  • Salve Medica Sp. z o.o.

    Lodz, 91-211

    Monika Kukulska, MD, PhD

    Recruiting

  • Zanamed Medical Clinic Sp. z o.o.

    Lublin, 20-601

    Michał Łoziński, MD

    Recruiting

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

    Malbork, 82-200

    Magdalena Wojanowska-Pindel, MD

    Not yet recruiting

  • Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o.

    Pleszew, 63-300

    Krzysztof Cieszyński, MD, PhD

    Not yet recruiting

  • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie

    Poznan, 61-866

    Active, not recruiting

  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka Sp. z. o.o.

    Słupsk, 76-200

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego PUM w Szczecinie

    Szczecin, 71-252

    Active, not recruiting

  • Metabolica Sp. z o.o.

    Tarnów, 33-100

    Robert Witek, MD

    Recruiting

  • Onkomedica Sp. z o.o.

    Warsaw, 01-934

    Paweł Morawski, MD

    Recruiting

  • Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

    Warsaw, 02-507

    Active, not recruiting

  • Wielospecjalistyczny Szpital Medicover

    Warsaw, 02-972

    Marek Durlik, Professor, MD, PhD

    Not yet recruiting

  • Military Institute of Medicine - National Research Institute

    Warsaw, 04-141

    Department of Gastroenterology and Internal Medicine, +48 261 817 599, dyrekcja@wim.mil.pl

    Maciej Gonciarz, Professor, MD, PhD

    Recruiting

  • Centrum Medyczne K2J2

    Wołomin, 05-200

    Katarzyna Kamińska-Stachniak, MD, PhD

    Not yet recruiting

  • 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu

    Wroclaw, 50-981

    Mateusz Tabin, MD, PhD

    Recruiting

Other trials in Poland

Italy7 sites, 7 recruiting

  • Gastroenterologia ed Endoscopia digestiva Ospedale "Morgagni - Pierantoni" di Forlì

    Forlì, 47121

    Carlo Fabbri, Professor, MD, PhD

    Not yet recruiting

  • Pancreas Translational and Clinical Center IRCCS Ospedale San Raffaele

    Milan, 20132

    Gabriele Capurso, Professor, MD, PhD

    Not yet recruiting

  • Unità di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia (IEO)

    Milan, 20141

    Lorenzo Gravaso, MD, PhD

    Not yet recruiting

  • SC Chirurgia Generale 1 Fondazione IRCCS Policlinico "San Matteo"

    Pavia, 27100

    Lorenzo Cobianchi, Professor, MD, PhD

    Not yet recruiting

  • UOC Gastroenterologia Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

    Massimo Bellini, Professor, MD, PhD

    Not yet recruiting

  • Unità Operativa Complessa di Endoscopia Digestiva Chirurgica Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168

    Cristiano Spada, Professor, MD, PhD

    Not yet recruiting

  • Unità Operativa di Chirurgia Pancreatica IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Alessandro Zerbi, Professor, MD, PhD

    Not yet recruiting

Other trials in Italy

Hungary5 sites, 5 recruiting

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

    Békéscsaba, 5600

    Márta Varga, MD

    Not yet recruiting

  • Pankreász Betegségek Intézete Semmelweis Egyetem

    Budapest, 1083

    Tibor Csőszi, MD

    Not yet recruiting

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000

    Péter Novák, MD

    Not yet recruiting

  • Csőszi Endoszkópos Kft.

    Kecskemét, 6000

    Tibor Csőszi, MD

    Recruiting

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Dr. Bugyi István Szentesi Multidiszciplináris Centrum

    Szentes, 6600

    László Nagy, MD

    Not yet recruiting

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Being tested
Panuri test
Keywords
in vitro diagnostic assay, clinical performance study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Panuri testDiagnostic test

    In vitro diagnostic assay designed to detect, in human urine samples pancreatic ductal adenocarcinoma

Study groups in NCT07587866
Study groupRoleWhat they receive
Arm 1 (Target Arm)patients presenting to healthcare providers with symptoms supporting a clinical suspicion of pancreatic cancer
Receives: Diagnostic Test: Panuri test
Arm 2 (Enriched Arm)patients scheduled for a procedure involving pancreatic cancer histopathological assessment
Receives: Diagnostic Test: Panuri test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start10 Jun 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587866
Sponsor's protocol ID
UR-CPS-01-2025
Status last verified
Jul 2026
First submitted
5 May 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Urteste S.A at 32 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Poland, Italy, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karolina Stanny (+48 572 722 750, karolina.stanny@urteste.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of the study is to estimate Panuri performance for the detection of PDAC. (time frame: From enrollment up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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