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

ConditionsPancreatic Adenocarcinoma (Ductal Adenocarcinoma)Early Detection of Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorSaskia Hendrich

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adults aged 60 years or older with defined metabolic or familial/genetic risk factors for pancreatic ductal adenocarcinoma, recruited through GP practices in Canton Zurich and adjacent cantons, or via self-presentation through the study website (spot-cancer.ch).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay)

    Diagnostic test

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Trigger-positive participants1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saskia Hendrich

Lead sponsor

Gastrointestinal Tumour Network Zurich (GITZ)

Sponsor institution

OnkoZentrum Zürich AG

Collaborator

Krebsliga Schweiz

Collaborator

Source ClinicalTrials.gov

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