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

N/ANot Yet RecruitingNCT07723781

Saskia Hendrich50 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)Early Detection of Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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 Outcomes

PancreaSure Biomarker Performance

Blinded exploratory characterisation of PancreaSure serum biomarker assay performance in a Swiss primary care population. Hypothesis-generating only; no inferential statistics planned.

Time frame: Through study completion, an average of 3 years

Multidisciplinary Tumour Board Process Characterisation

Descriptive characterisation of the MDT tumour board process including case volume, time from MRI to board discussion, and board composition.

Time frame: 24 months

GP Experience with Study Pathway

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.

Time frame: 24 months

Participant Experience with Study Pathway

Structured assessment of participant-reported experience with the study pathway including perceived burden, satisfaction with communication, and willingness to recommend participation.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts