Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers

NCT ID: NCT04449406

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Pancreatic Ductal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liverpool

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Pancreatic Cancer Research Fund

UNKNOWN

Sponsor Role collaborator

Ospedale San Raffaele

OTHER

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tatjana Crnogorac-Jurcevic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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EUROPAC study, University of Liverpool

Liverpool, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

ADEPTS study, University College London

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Imperial College London

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Royal London Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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UroPanc Coordinator

Role: CONTACT

020 7882 8497

Facility Contacts

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UroPanc Coordinator

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26240291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31857725 (View on PubMed)

Other Identifiers

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012335QM

Identifier Type: -

Identifier Source: org_study_id

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