Hereditary pancreatic cancer early surveillance program

1. Approved 22/12/2025, Komisija Republike Slovenije za medicinsko etiko (Štefanova ulica 5, Ljubljana, 1000, Slovenia; +386 1 478 69 06; kme.mz@gov.si), ref: 0120-650/2025-2711-3

2. Approved 26/10/2025, Comité de ética de investigación clinica (Avda. Montepríncipe, 25., Madrid, 28660, Spain; +34 91 708 99 00, ext. 12588.; Secretaria.ceic@hmhospitales.com), ref: CEIm code 25.10.2611-GHM

3. Submitted 06/01/2026, Nationalt Center for Etik, Råd og Komitéer (Ørestads Boulevard 5, København S, 2300, Denmark; N/A; dketik@dketik.dk), ref: Not Assgined Yet

4. Submitted 02/02/2026, Research Ethics Commitee of the National and Kapodistrian University of Athens (Christou Lada 6, Athens, 10676, Greece; +30 6974006084; diradmin@uoa.gr), ref: Not assigned yet

5. Submitted 18/12/2025, Etikprövningmhyndigheten (Box 2110, Uppsala, 75002, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: Not assigned yet

6. Submitted 06/01/2026, Comité d'Éthique Hospitalo-Facultaire Universitaire de Liège (CHU de Liège, Sart Tilman, Liege, 4000, Belgium; +32 4 323 21 58; ethique@chuliege.be), ref: Not assigned yet

1. Tier1: Proportion of approached individuals who use the public-facing interfaces and who meet SHIELD high-risk eligibility criteria based on genetic results measured using recruitment funnel metrics captured via platform logs and site screening logs: (1) number approached/invited, (2) number who engage with the public-facing interface (e.g., web/chat), (3) number triaged to a site, (4) number consented and genetically tested, (5) number meeting SHIELD high-risk eligibility based on germline testing and eligibility evaluation; eligibility is determined using targeted NGS results plus predefined criteria recorded in study records/eCRF at continuously, summarised at defined recruitment cut-offs (interim and end of recruitment)
2. Tier2: Longitudinal adherence rate to annual follow-up schedule (e.g., MRI completion and blood sampling) measured using for each scheduled annual surveillance cycle, proportion completing required components (MRI and blood sampling) within protocol-defined windows; MRI is scheduled/performed in relation to the surveillance blood test within the protocol window (no later than 6 months after blood test; coordination guidance also allows alignment with prior/next imaging for those already in surveillance) at annual follow-up visit (12-month intervals) and cumulatively across follow-up until study end/withdrawal/diagnosis
3. Tier2: Completeness and quality of the surveillance dataset (clinical, imaging, genetic, biospecimen data) measured using data completeness/quality indicators derived from eCRF and supporting records: completeness of required fields and visit forms, availability/quality of imaging reports, completeness of biospecimen chain-of-custody (collection, processing, aliquoting, shipment/biobank receipt), and documentation of deviations at At each surveillance visit and cumulatively at data cut and study close-out
4. Tier 3: Sensitivity measured using proportion of true PDAC cases correctly identified by the Reccan-IA test against the clinical reference standard at when participant’s blood sample is collected for the test and when the corresponding clinical disease status is established by MRI (and histopathology when applicable)
5. Tier3: Specificity measured using proportion of non-PDAC individuals correctly identified by the Reccan-IA test against the clinical reference standard at when participant’s blood sample is collected for the test and when the corresponding clinical disease status is established by MRI (and histopathology when applicable)

1. Frequency of pathogenic or likely pathogenic variants measured using Proportion and distribution of participants with pathogenic/likely pathogenic variants in the targeted panel; measured from germline testing results (targeted NGS panel) and variant classification recorded in study records at Once per participant when genetic results are available;
2. Proportion of genetically high-risk individuals enrolled into the clinical validation of Reccan-IA measured using Proportion: numerator = participants classified as genetically high-risk who enrol into the downstream validation component; denominator = all participants classified as genetically high-risk; measured from eligibility categorisation and Tier 3 enrolment records at cumulative, from the point of genetic eligibility determination through end of enrolment into Tier 3
3. Incidence of PDAC or high-grade precursor lesions detected during surveillance measured using rate of PDAC and/or high-grade precursor lesions detected; determined through surveillance imaging (annual MRI; EUS if MRI cannot be performed) and clinical outcome documentation, with histopathology confirmation when applicable at longitudinally during annual follow-up until diagnosis, withdrawal, or programme closure
4. PPV and NPV of Reccan-IA measured using Positive predictive value and negative predictive value against the clinical reference standard at after results and reference standard status are available for the relevant participants
5. Performance in different high-risk subgroups (familial high-risk, genetic high-risk, and NOD) measured using performance metrics (at minimum sensitivity/specificity; PPV/NPV if planned) computed within subgroup definitions captured in the dataset at when subgroup classification and reference standard outcomes are available
6. Sensitivity for early-stage PDAC measured using Sensitivity specifically for early-stage PDAC (stage I–II) versus reference standard (MRI ± histopathology when applicable) at after staging and reference standard diagnosis are confirmed