Pancreatic Ductal AdenocarcinomaUroPancNCT04449406
Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers
An observational study of Pancreatic Ductal Adenocarcinoma, run by Queen Mary University of London at 4 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- How many people
- 3,500 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jan 2020to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples from symptomatic and asymptomatic individuals at risk of PDAC will be provided to the UroPanc team by collaborating centres via dedicated tissue banks/registries already in place at UCL (ADEPTS) and the University of Liverpool (EUROPAC). Symptomatic individuals at risk which are being referred to specialist care by their general practitioners (GPs) will be recruited to participate in UroPanc when attending clinics (gastroenterology clinics, endoscopy units and Multidisciplinary Diagnostic Centres (MDCs)) at a participating study site.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
EUROPAC study, University of Liverpool
Liverpool
ADEPTS study, University College London
London
Imperial College London
London
Royal London Hospital
London
About this study
Official title: Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers (UroPanc)
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.
Read the detailed description
The main aim of this research study is to establish the accuracy of a urinary biomarker panel (LYVE1, REG1B, TFF1), and affiliated PancRISK score alone or in combination with plasma CA19-9 for early detection of pancreatic ductal adenocarcinoma (PDAC).
Samples will be collected from symptomatic individuals with suspected pancreatic cancer, and asymptomatic subjects at risk of developing PDAC.
The results of urine biomarker and CA19-9 analysis carried out on these samples will be compared to the imaging and, where available, histopathology data, which will inform the development of a predictive model to detect PDAC earlier.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Biomarker, PDAC, Pancreatic cancer, CA19-9, Urine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals at risk of developing PDAC | * 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of biomarker panel and affiliated risk score
Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
Measured: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Secondary outcomes (2)
Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result
Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
Measured: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Economic and social impact of using biomarker panel for PDAC testing
Stakeholder and health economics analyses of the inclusion of the urine test into the existing diagnostic and surveillance pathways for PDAC.
Measured: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jan 2020
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, University College, London, Imperial College London, Pancreatic Cancer Research Fund, Ospedale San Raffaele
- Responsible party
- Sponsor
- Investigators
- Tatjana Crnogorac-Jurcevic, MD, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449406
- Sponsor's protocol ID
- 012335QM
- Acronym
- UroPanc
- Status last verified
- Apr 2026
- First submitted
- 5 May 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Debernardi 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.
PubMed 33301466Debernardi 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.
PubMed 36093581Radon 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.
PubMed 26240291Blyuss 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.
PubMed 31857725
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers (UroPanc)
- ClinicalTrials.gov ID
- NCT04449406
- Acronym / sponsor ID
- UroPanc / 012335QM
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Biomarker, PDAC, Pancreatic cancer, CA19-9, Urine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Liverpool, University College, London, Imperial College London, Pancreatic Cancer Research Fund, Ospedale San Raffaele
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main aim of this research study is to establish the accuracy of a urinary biomarker panel (LYVE1, REG1B, TFF1), and affiliated PancRISK score alone or in combination with plasma CA19-9 for early detection of pancreatic ductal adenocarcinoma (PDAC).
Samples will be collected from symptomatic individuals with suspected pancreatic cancer, and asymptomatic subjects at risk of developing PDAC.
The results of urine biomarker and CA19-9 analysis carried out on these samples will be compared to the imaging and, where available, histopathology data, which will inform the development of a predictive model to detect PDAC earlier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals at risk of developing PDAC | – | –* 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples from symptomatic and asymptomatic individuals at risk of PDAC will be provided to the UroPanc team by collaborating centres via dedicated tissue banks/registries already in place at UCL (ADEPTS) and the University of Liverpool (EUROPAC). Symptomatic individuals at risk which are being referred to specialist care by their general practitioners (GPs) will be recruited to participate in UroPanc when attending clinics (gastroenterology clinics, endoscopy units and Multidisciplinary Diagnostic Centres (MDCs)) at a participating study site.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of biomarker panel and affiliated risk score
Time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
2 secondary outcomes
Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result
Time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Economic and social impact of using biomarker panel for PDAC testing
Time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 33301466Debernardi 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.
- Background: PubMed 36093581Debernardi 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.
- Background: PubMed 26240291Radon 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.
- Background: PubMed 31857725Blyuss 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatjana Crnogorac-Jurcevic, MD, PhD principal investigator
Queen Mary University of London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma, run by Queen Mary University of London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of biomarker panel and affiliated risk score (time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449406, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.