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

NCT07723781 | Not Yet Recruiting

• 1 other identifier: PANCATCH-Pilot-2026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma (Ductal Adenocarcinoma); Early Detection of Cancer

Keywords

Pancreatic cancer; Case finding; Primary care; Feasibility study; MRI screening; PancreaSure; PDAC; Switzerland

Outcome Measures

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.

  24 months

Secondary Outcomes (4)

• 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

Study Arms (1)

Trigger-positive participants

Adults aged 60 years or older with at least one metabolic trigger (new-onset type 2 diabetes ≤24 months combined with unintentional weight loss \>5% in 3 months) or familial/genetic trigger (family history of PDAC or BRCA1/2/CDKN2A germline mutation), recruited through GP referral or self-presentation via study website.

Diagnostic Test: Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay)

Interventions

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.

Trigger-positive participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saskia Hendrich: lead
• OnkoZentrum Zürich AG: collaborator
• Krebsliga Schweiz: collaborator

Study Sites (1)

Onkozentrum Zürich AG

Zurich, Canton of Zurich, 8038, Switzerland

Location

Related Publications (3)

• Roychoudhury S, et al. Bayesian approaches to phase II trials. Stat Med. 2018 (dual-criterion feasibility framework)

  BACKGROUND

• Aslanian HR, Lee JH, Canto MI. AGA Clinical Practice Update on Pancreas Cancer Screening in High-Risk Individuals: Expert Review. Gastroenterology. 2020 Jul;159(1):358-362. doi: 10.1053/j.gastro.2020.03.088. Epub 2020 May 19.

  PMID: 32416142 BACKGROUND

• Clift AK, Tan PS, Patone M, Liao W, Coupland C, Bashford-Rogers R, Sivakumar S, Hippisley-Cox J. Predicting the risk of pancreatic cancer in adults with new-onset diabetes: development and internal-external validation of a clinical risk prediction model. Br J Cancer. 2024 Jun;130(12):1969-1978. doi: 10.1038/s41416-024-02693-9. Epub 2024 May 3.

  PMID: 38702436 BACKGROUND

Related Links

• SPOT Pancreatic cancer

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples (native, non-additive tubes). Two aliquots per participant: one analysis aliquot for blinded PancreaSure biomarker assay (Immunovia Inc., Durham, NC, USA) and one backup aliquot for study biobank. Storage at -80°C at Biobank Balgrist Campus, Zurich, Switzerland. Retention period: analysis aliquots up to 24 months from first sample; backup aliquots 10 years after study completion (per HRA Art. 45).

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jan Schmidt, Professor

  Swiss Surgery, Klinik Im Park, Hirslanden, Zurich

  STUDY DIRECTOR

• Alexander Siebenhüner, PD

  Hirslanden Cancer Institute, Klinik Im Park, Zurich Role: Study Director

  STUDY DIRECTOR

Central Study Contacts

Saskia AD Hendrich, MD

CONTACT

+41 43 344 33 33; saskia.hendrich@ozh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)