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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Panuri test
Diagnostic testIn vitro diagnostic assay designed to detect, in human urine samples pancreatic ductal adenocarcinoma
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Arm 1 (Target Arm)1 intervention
Group B: Arm 2 (Enriched Arm)1 intervention
Trial outcomes
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.
Time frame
From enrollment up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: