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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Composite Feasibility Score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Composite Feasibility Score
Time Frame: 24 months
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
- PancreaSure Biomarker Performance(Through study completion, an average of 3 years)
- Multidisciplinary Tumour Board Process Characterisation(24 months)
- GP Experience with Study Pathway(24 months)
- Participant Experience with Study Pathway(12 months)
Investigators
Saskia Hendrich
Study Principal Investigator
Gastrointestinal Tumour Network Zurich (GITZ)