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Not yet recruiting NCT07723781

Structured Case-Finding for Pancreatic Ductal Adenocarcinoma in Swiss Primary Care: A Feasibility Study

— Observational Pancreatic Adenocarcinoma (Ductal Adenocarcinoma) Early Detection of Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay).
Who it may be relevant to
Registry conditions: Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Early Detection of Cancer. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PANCATCH-Pilot: Structured Early Detection of Pancreatic Ductal Adenocarcinoma in Swiss Primary Care - A Prospective Feasibility Study of a Case-Finding Pathway in the Canton of Zurich

Overview

Pancreatic ductal adenocarcinoma (PDAC) is diagnosed at an advanced, incurable stage in more than 80% of cases in Switzerland. Certain warning signs - new-onset diabetes, unexplained weight loss, or a family history of pancreatic cancer - may indicate elevated risk, but are not systematically assessed in primary care. PANCATCH-Pilot tests whether a structured case-finding pathway in Swiss general practices is feasible. Adults aged 60 years or older with one or more of these risk factors are invited to undergo an MRI/MRCP examination of the pancreas and a blood draw for a blinded biomarker test (PancreaSure, Immunovia Inc.). Findings are reviewed by a multidisciplinary tumour board. The goal is not treatment, but to assess whether such a pathway works in the Swiss primary care context - as preparation for a larger national study. The study enrolls 50 trigger-positive participants over 24 months through two parallel recruitment pathways: GP referral and self-presentation via a study website. Feasibility is assessed using six combined endpoints covering recruitment, process quality, safety, and equity.

Interventions

  • Diagnostic test Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay)
    Single-visit structured pathway comprising: (1) standardised clinical risk assessment; (2) MRI/MRCP with macrocyclic gadolinium contrast agent (Dotarem) per PRECEDE consensus protocol; (3) blood draw for blinded PancreaSure serum biomarker assay (Immunovia Inc.) and study biobank; (4) multidisciplinary tumour board review. No therapeutic intervention.

Primary outcome measures

  • Composite Feasibility Score [Time frame: 24 months]
Secondary outcome measures (4)
  • PancreaSure Biomarker Performance [Time frame: Through study completion, an average of 3 years]
  • Multidisciplinary Tumour Board Process Characterisation [Time frame: 24 months]
  • GP Experience with Study Pathway [Time frame: 24 months]
  • Participant Experience with Study Pathway [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Age 60 years or older
  • Attendance at a participating GP practice in Canton Zurich or adjacent canton (maximum 1 hour travel time), or self-presentation via study microsite
  • At least one trigger criterion fulfilled: metabolic trigger (new-onset type 2 diabetes mellitus diagnosed within 24 months AND unintentional weight loss >5% body weight within 3 months) OR familial/genetic trigger (≥2 first-degree relatives with PDAC, or ≥1 first-degree relative with PDAC, or BRCA1/2 germline mutation, or CDKN2A mutation); combined with age ≥60 years
  • Written informed consent
  • Sufficient German or English language skills for study communication

Exclusion criteria

  • Prior or current diagnosis of pancreatic carcinoma or pre-malignant pancreatic lesion
  • Contraindication to MRI (metallic implants, severe claustrophobia without available alternative)
  • Active untreated psychiatric condition impairing capacity to consent
  • Pregnancy
  • Incapacity to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Onkozentrum Zürich AG — Zurich

Publications

  • Roychoudhury S, et al. Bayesian approaches to phase II trials. Stat Med. 2018 (dual-criterion feasibility framework)
  • Aslanian HR, Lee JH, Canto MI. AGA Clinical Practice Update on Pancreas Cancer Screening in High-Risk Individuals: Expert Review. Gastroenterology. 2020 Jul;159(1):358-362. doi: 10.1053/j.gastro.2020.03.088. Epub 2020 May 19. PMID 32416142
  • Clift AK, Tan PS, Patone M, Liao W, Coupland C, Bashford-Rogers R, Sivakumar S, Hippisley-Cox J. Predicting the risk of pancreatic cancer in adults with new-onset diabetes: development and internal-external validation of a clinical risk prediction model. Br J Cancer. 2024 Jun;130(12):1969-1978. doi: 10.1038/s41416-024-02693-9. Epub 2024 May 3. PMID 38702436

Identifiers

NCT: NCT07723781 · PANCATCH-Pilot-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗