Panuri Performance Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUrteste S.A
About this trial
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.
Eligibility criteria
Qualifiers
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.
Adults 18 years and older
Scheduled for a procedure involving pancreatic histopathological assessment due to suspicion of pancreatic cancer.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Panuri test
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov