NCT04449406

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2020Aug 2026

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

May 5, 2020

Last Update Submit

January 5, 2026

Conditions

Keywords

BiomarkerPDACPancreatic cancerCA19-9Urine

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    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

    Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)

Study Arms (1)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

EUROPAC study, University of Liverpool

Liverpool, United Kingdom

ACTIVE NOT RECRUITING

ADEPTS study, University College London

London, United Kingdom

ACTIVE NOT RECRUITING

Imperial College London

London, United Kingdom

ACTIVE NOT RECRUITING

Royal London Hospital

London, United Kingdom

RECRUITING

Related Publications (2)

  • Radon 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: 26240291BACKGROUND
  • Blyuss 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: 31857725BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine and blood samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Tatjana Crnogorac-Jurcevic, MD, PhD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

UroPanc Coordinator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

June 26, 2020

Study Start

January 1, 2020

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations