Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)PANCATCH-PilotNCT07723781
Structured Case-Finding for Pancreatic Ductal Adenocarcinoma in Swiss Primary Care: A Feasibility Study
An observational study of Pancreatic Adenocarcinoma (Ductal Adenocarcinoma) and Early Detection of Cancer, run by Saskia Hendrich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Early Detection of Cancer
- What is being tested?
- Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay)
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 30 Sep 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Onkozentrum Zürich AG
Zurich, Canton of Zurich, 8038
Saskia AD Hendrich, MD, +41 43 344 33 33, saskia.hendrich@ozh.ch
About this study
Official 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
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.
- Being tested
- Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay)
- Keywords
- Pancreatic cancer, Case finding, Primary care, Feasibility study, MRI screening, PancreaSure, PDAC, Switzerland
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Structured case-finding pathway (MRI/MRCP + PancreaSure biomarker assay) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saskia Hendrich
- Sponsor type
- University, hospital or other
- Collaborators
- OnkoZentrum Zürich AG, Krebsliga Schweiz
- Responsible party
- Sponsor-investigator, Saskia Hendrich, Gastrointestinal Tumour Network Zurich (GITZ)
- Investigators
- Jan Schmidt, Professor, Study director, Swiss Surgery, Klinik Im Park, Hirslanden, ZurichAlexander Siebenhüner, PD, Study director, Hirslanden Cancer Institute, Klinik Im Park, Zurich Role: Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723781
- Sponsor's protocol ID
- PANCATCH-Pilot-2026
- Acronym
- PANCATCH-Pilot
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to Swiss data protection regulations (revDSG) and the pseudonymisation framework of the study. Aggregated results will be published open access.
Publications
Roychoudhury S, et al. Bayesian approaches to phase II trials. Stat Med. 2018 (dual-criterion feasibility framework)
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.
PubMed 32416142Clift 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.
PubMed 38702436