Clinical trial · Observational
Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers
Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers (UroPanc)
NCT04449406CI-TRIAL-00107551UroPancactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Urine and blood samples are being collected from patients with and without diseases of the pancreas. These samples will be tested with the aim of developing an accurate way of diagnosing diseases of the pancreas using the results.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Individuals at risk of developing PDAC
- description
- * Symptomatic participants (via direct recruitment to UroPanc and via study/tissue bank(s) i.e. UCL ADEPTs study) * Asymptomatic participants (via study/tissue bank(s) i.e. University of Liverpool EUROPAC registry) Medical history, demographic information and concomitant medications information will be collected at baseline, together with blood and urine samples. Urinary biomarkers and plasma CA19-9 will be measured and the results compared with imaging data (and pathology, if it becomes available).
Primary outcomes (1)
- measure
- Accuracy of biomarker panel and affiliated risk score
- timeFrame
- Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
- description
- Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
Secondary outcomes (2)
- measure
- Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria (Symptomatic patients): * Able and willing to give informed consent * ≥18 years old * Suspected pancreatic diseases with symptoms including, but not limited to, diarrhoea, back pain, abdominal pain, nausea, vomiting, constipation or new onset diabetes Exclusion criteria (Symptomatic patients): * Current or prior treatment (chemotherapy, radiotherapy, surgical resection, biological therapy, and immunotherapy) for any malignancy other than basal cell carcinoma within 5 years of enrolment. Asymptomatic participants will be identified through the EUROPAC registry and will fulfil EUROPAC's eligibility criteria.
References
Publications (4)
- BACKGROUNDDebernardi S, O'Brien H, Algahmdi AS, Malats N, Stewart GD, Pljesa-Ercegovac M, Costello E, Greenhalf W, Saad A, Roberts R, Ney A, Pereira SP, Kocher HM, Duffy S, Blyuss O, Crnogorac-Jurcevic T. A combination of urinary biomarker panel and PancRISK score for earlier detection of pancreatic cancer: A case-control study. PLoS Med. 2020 Dec 10;17(12):e1003489. doi: 10.1371/journal.pmed.1003489. eCollection 2020 Dec. PMID 33301466
- BACKGROUNDDebernardi S, Blyuss O, Rycyk D, Srivastava K, Jeon CY, Cai H, Cai Q, Shu XO, Crnogorac-Jurcevic T. Urine biomarkers enable pancreatic cancer detection up to 2 years before diagnosis. Int J Cancer. 2023 Feb 15;152(4):769-780. doi: 10.1002/ijc.34287. Epub 2022 Sep 23. PMID 36093581
- BACKGROUNDRadon TP, Massat NJ, Jones R, Alrawashdeh W, Dumartin L, Ennis D, Duffy SW, Kocher HM, Pereira SP, Guarner posthumous L, Murta-Nascimento C, Real FX, Malats N, Neoptolemos J, Costello E, Greenhalf W, Lemoine NR, Crnogorac-Jurcevic T. Identification of a Three-Biomarker Panel in Urine for Early Detection of Pancreatic Adenocarcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3512-21. doi: 10.1158/1078-0432.CCR-14-2467. PMID 26240291
- BACKGROUNDBlyuss O, Zaikin A, Cherepanova V, Munblit D, Kiseleva EM, Prytomanova OM, Duffy SW, Crnogorac-Jurcevic T. Development of PancRISK, a urine biomarker-based risk score for stratified screening of pancreatic cancer patients. Br J Cancer. 2020 Mar;122(5):692-696. doi: 10.1038/s41416-019-0694-0. Epub 2019 Dec 20. PMID 31857725