Clinical trialObsRecruiting
Panuri Performance Study
Evaluation of the Performance of Panuri - Test for Detection of Pancreatic Ductal Adenocarcinoma
- Outcome
- Ongoing
- Phase
- Obs
- Status
- Recruiting
- Study type
- Observational
- Start
- 10 June 2026
- Expected end
- January 2028
- Enrollment
- 1,100 participants
- Sites
- 32
- Primary outcomes
- The primary objective of the study is to estimate Panuri performance for the detection of PDAC.
- Sponsor
- Industry
- Results posted
- No
- Last update
- 23 July 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.