Panuri Performance Study

NCT07587866 | Not Yet Recruiting

• 1 other identifier: UR-CPS-01-2025
• Study Type: observational
• Target: 1,100
• Locations: 3 countries
• Sites: 28

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)

Keywords

in vitro diagnostic assay; clinical performance study

Outcome Measures

Primary Outcomes (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.

  From enrollment up to 6 months

Study Arms (2)

Arm 1 (Target Arm)

patients presenting to healthcare providers with symptoms supporting a clinical suspicion of pancreatic cancer

Diagnostic Test: Panuri test

Arm 2 (Enriched Arm)

patients scheduled for a procedure involving pancreatic cancer histopathological assessment

Diagnostic Test: Panuri test

Interventions

Panuri test DIAGNOSTIC_TEST

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

Arm 1 (Target Arm); Arm 2 (Enriched Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Urteste S.A: lead

Study Sites (28)

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

Békéscsaba, 5600, Hungary

Location

Pankreász Betegségek Intézete Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, 6000, Hungary

Location

Csőszi Endoszkópos Kft.

Kecskemét, 6000, Hungary

Location

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

Szentes, 6600, Hungary

Location

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

Forlì, 47121, Italy

Location

Pancreas Translational and Clinical Center IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

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

Milan, 20141, Italy

Location

SC Chirurgia Generale 1 Fondazione IRCCS Policlinico "San Matteo"

Pavia, 27100, Italy

Location

UOC Gastroenterologia Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

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

Roma, 00168, Italy

Location

Unità Operativa di Chirurgia Pancreatica IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

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

Dąbrowa Tarnowska, 33-200, Poland

Location

SPZOZ Uniwersyteckie Centrum Kliniczne Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej

Gdansk, 80-214, Poland

Location

Przychodnia KOPERNIKA Sp. z o.o.

Grudziądz, 86-300, Poland

Location

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

Iława, 14-200, Poland

Location

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

Krakow, 30-074, Poland

Location

Salve Medica Sp. z o.o.

Lodz, 91-211, Poland

Location

ZANA-MED MEDICAL GROUP Sp. z o.o.

Lublin, 20-601, Poland

Location

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie

Poznan, 61-866, Poland

Location

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

Szczecin, 71-252, Poland

Location

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

Słupsk, 76-200, Poland

Location

Metabolica Sp. z o.o.

Tarnów, 33-100, Poland

Location

Onkomedica Sp. z o.o.

Warsaw, 01-934, Poland

Location

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji

Warsaw, 02-507, Poland

Location

Military Institute of Medicine - National Research Institute

Warsaw, 04-141, Poland

Location

Centrum Medyczne K2J2

Wołomin, 05-200, Poland

Location

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

Wroclaw, 50-981, Poland

Location

Central Study Contacts

Karolina Stanny

CONTACT

+48 572 722 750; karolina.stanny@urteste.eu

Aurevia Poland Sp. z o.o.

CONTACT

office@aurevia.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

HU (5); IT (7); PL (16)