Panuri test in suspected pancreatic cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-site, enriched, observational, non-interventional study to characterize how well the Panuri test detects pancreatic ductal adenocarcinoma in symptomatic adults. Participants are enrolled in two arms: a target arm with patients presenting symptoms suggesting pancreatic cancer, and an enriched arm including those scheduled for pancreatic tissue assessment. The Panuri assay measures proteolytic enzyme activity in urine and is used alongside standard diagnostic workup to help determine if further imaging may be needed; reference standard diagnosis is determined via electronic health record review. Blinding is maintained for both participants and physicians to Panuri results. Outcomes focus on the diagnostic performance of Panuri in real-world clinical settings.

Why it matters

Who can join: the full rules

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)

Where it's running

• Csőszi Endoszkópos Kft.
  Kecskemét, Hungary Recruiting
• Niepubliczny Zakład Opieki Zdrowotnej "Diagmed" J.Bajorek, N.Kopeć Spółka Jawna
  Dąbrowa Tarnowska, Poland Recruiting
• Przychodnia KOPERNIKA Sp. z o.o.
  Grudziądz, Poland Recruiting
• Ośrodek Badań Klinicznych BD Research Sp. z o.o.
  Iława, Poland Recruiting
• Salve Medica Sp. z o.o.
  Lodz, Poland Recruiting
• Zanamed Medical Clinic Sp. z o.o.
  Lublin, Poland Recruiting

Study contacts

• Study coordinator: Karolina Stanny
• Email: karolina.stanny@urteste.eu
• Phone: +48 572 722 750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.