Early Detection of Cancer, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
Conditions
Keywords
Pancreatic cancer, Case finding, Primary care, Feasibility study, MRI screening, PancreaSure, PDAC, Switzerland
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.
Interventions
DIAGNOSTIC_TESTStructured 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.
Sponsors
Saskia Hendrich
OnkoZentrum Zürich AG
Krebsliga Schweiz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Feasibility Score | 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
| Measure | Time frame | Description |
|---|---|---|
| PancreaSure Biomarker Performance | Through study completion, an average of 3 years | Blinded exploratory characterisation of PancreaSure serum biomarker assay performance in a Swiss primary care population. Hypothesis-generating only; no inferential statistics planned. |
| Multidisciplinary Tumour Board Process Characterisation | 24 months | Descriptive characterisation of the MDT tumour board process including case volume, time from MRI to board discussion, and board composition. |
| GP Experience with Study Pathway | 24 months | Semi-structured questionnaire assessing GP experience with the case-finding pathway, including perceived burden, clarity of trigger criteria, and willingness to participate in a national main trial. |
| Participant Experience with Study Pathway | 12 months | Structured assessment of participant-reported experience with the study pathway including perceived burden, satisfaction with communication, and willingness to recommend participation. |
Countries
Switzerland
Contacts
CONTACTSaskia AD Hendrich, MD
STUDY_DIRECTORJan Schmidt, Professor
Swiss Surgery, Klinik Im Park, Hirslanden, Zurich
STUDY_DIRECTORAlexander Siebenhüner, PD
Hirslanden Cancer Institute, Klinik Im Park, Zurich Role: Study Director
Outcome results
None listed