Panuri Performance Study

Recruiting now

Conditions studied: Pancreatic Ductal Adenocarcinoma (PDAC)

In brief

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.

Key facts

Study ID

NCT07587866

Run by

Urteste S.A

People needed

1100

Starts

2026-06-10

Expected to finish

2028-01-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Niepubliczny Zakład Opieki Zdrowotnej "Diagmed" J.Bajorek, N.Kopeć Spółka Jawna — Dąbrowa Tarnowska, Poland (enrolling)
• Csőszi Endoszkópos Kft. — Kecskemét, Hungary (enrolling)
• Salve Medica Sp. z o.o. — Lodz, Poland (enrolling)
• Metabolica Sp. z o.o. — Tarnów, Poland (enrolling)
• Onkomedica Sp. z o.o. — Warsaw, Poland (enrolling)
• Zanamed Medical Clinic Sp. z o.o. — Lublin, Poland (enrolling)
• Przychodnia KOPERNIKA Sp. z o.o. — Grudziądz, Poland (enrolling)
• Military Institute of Medicine - National Research Institute — Warsaw, Poland (enrolling)
• Ośrodek Badań Klinicznych BD Research Sp. z o.o. — Iława, Poland (enrolling)
• 4 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej we Wrocławiu — Wroclaw, Poland (enrolling)
• Unità Operativa di Chirurgia Pancreatica IRCCS Istituto Clinico Humanitas — Rozzano, Italy
• SPZOZ Uniwersyteckie Centrum Kliniczne Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej — Gdansk, Poland
• Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház — Békéscsaba, Hungary
• Comarch Healthcare S.A. Centrum Medyczne iMed24 — Krakow, Poland
• Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o. — Malbork, Poland
• Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. — Pleszew, Poland
• Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie — Poznan, Poland
• Uniwersytecki Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego PUM w Szczecinie — Szczecin, Poland
• Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka Sp. z. o.o. — Słupsk, Poland
• Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji — Warsaw, Poland
• Wielospecjalistyczny Szpital Medicover — Warsaw, Poland
• Centrum Medyczne K2J2 — Wołomin, Poland
• OŚRODEK MEDYCZNY "OSTEOMED" S.C. Mirosław Szlachcic, Ewa Szlachcic — Krakow, Poland
• Pankreász Betegségek Intézete Semmelweis Egyetem — Budapest, Hungary
• Bács-Kiskun Vármegyei Oktatókórház — Kecskemét, Hungary

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.