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NCT Number: NCT07723781

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

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.

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Key information

Conditions

Pancreatic Adenocarcinoma (Ductal Adenocarcinoma) Digestive System Diseases Digestive System Neoplasms Early Detection of Cancer Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. PancreaSure Biomarker Performance

    Time frame: 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.

  2. Multidisciplinary Tumour Board Process Characterisation

    Time frame: 24 months

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

  3. GP Experience with Study Pathway

    Time frame: 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.

  4. Participant Experience with Study Pathway

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Saskia AD Hendrich, MD

CONTACT

[email protected]

+41 43 344 33 33

Sponsors and collaborators

Lead sponsor

Saskia Hendrich

Other

Collaborators

  • Krebsliga Schweiz
  • OnkoZentrum Zürich AG

Registry information

Official study title

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

Acronym: PANCATCH-Pilot

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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