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

Brief summary public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

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.

Arm public domain (ClinicalTrials.gov)

Trigger-positive participants (): 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.

Primary outcome public domain (ClinicalTrials.gov)

Composite Feasibility Score. 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. Time frame: 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

PancreaSure Biomarker Performance. Time frame: Through study completion, an average of 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Multidisciplinary Tumour Board Process Characterisation. Time frame: 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

GP Experience with Study Pathway. Time frame: 24 months.

Secondary outcome public domain (ClinicalTrials.gov)

Participant Experience with Study Pathway. Time frame: 12 months.

Eligibility public domain (ClinicalTrials.gov)

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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 50 participants (estimated).