Clinical trial · Observational
Structured Case-Finding for Pancreatic Ductal Adenocarcinoma in Swiss Primary Care: A Feasibility Study
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
- 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Detection of Cancer | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Adenocarcinoma (Ductal Adenocarcinoma) | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trigger-positive participants
- description
- Adults aged 60 years or older with at least one metabolic trigger (new-onset type 2 diabetes ≤24 months combined with unintentional weight loss \>5% in 3 months) or familial/genetic trigger (family history of PDAC or BRCA1/2/CDKN2A germline mutation), recruited through GP referral or self-presentation via study website.
- interventionNames
- Diagnostic Test: Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay)
Primary outcomes (1)
- measure
- Composite Feasibility Score
- timeFrame
- 24 months
- description
- Feasibility assessed by dual-criterion approach (Roychoudhury et al. 2018) across 6 combined endpoints: (1) GP recruitment rate ≥60%; (2) trigger documentation rate ≥70%; (3) T0-T4 time window median ≤21 days; (4) data completeness ≥85%; (5) harm indicator (invasive follow-up procedures) ≤25%; (6) equity index (Spread Quotient ≤4 and Representation Index 0.7-1.3). Study success criterion: ≥5 of 6 endpoints meet both target value and acceptance threshold.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDRoychoudhury S, et al. Bayesian approaches to phase II trials. Stat Med. 2018 (dual-criterion feasibility framework)
- BACKGROUNDAslanian 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
- BACKGROUNDClift 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