Pancreatic ductal adenocarcinoma (PDAC) Cancer
Conditions
Interventions
The study is designed as a prospective, multicentre, non-interventional, longitudinal observational surveillance and sample-collection programme in adults with increased hereditary and/or familial ris
Sponsors
Univerzitetni klinicni center Maribor
Lund University
Ethniko kai Kapodistriako Panepistimio Athinon
Vilnius University
Centre Hospitalier Universitaire de Liège
Region Syddanmark
Hospital Universitario HM Sanchinarro / Fundación de Investigación HM Hospitales
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Tier 1 - eligibility assessment 1. Ability to sign the eConsent 2. Age >= 18 Tier 1 - genetic evaluation 3. Individuals with a personal or family history suggestive of heritable pancreatic cancer syndromes, age 40+ (or 10 years younger than the youngest affected family member’s age at onset, per the protocol text). 4. Family-history patterns that can qualify include (examples listed in the protocol): 1 first-degree relative (FDR) with PDAC (with additional qualifiers/limits), 1 FDR plus other cancers/risk factors (e.g., NOD, pancreatitis, IPMN), 2 second-degree relatives (SDR), or meeting CAPS criteria (Annex referenced). 5. Individuals with newly diagnosed pancreatic cancer (age =18) are eligible to enter Tier 2 directly per the Tier 1 synopsis. Tier 2 - Surveillance program & sample collection 1. Written informed consent and adult age =18 years. 2. Either: treatment-naïve, confirmed PDAC (with preferred stage distribution targets/limits noted in the protocol), included to build a reference cohort. 3. Or: “overall healthy” individuals with familial/hereditary risk, including any of the following high-risk categories: familial clustering patterns (e.g., =2 relatives with PDAC with at least one FDR; or two affected FDRs), or carriers of specific pathogenic/likely pathogenic variants with required family history and age thresholds (e.g., BRCA1/2, PALB2, ATM with an affected FDR/SDR; CDKN2A/FAMMM; STK11/Peutz-Jeghers; Lynch genes with affected FDR/SDR; PRSS1 hereditary pancreatitis with pancreatitis history). Tier 3 - Validation & Biomarker Discovery 1. Participants enrolled in the SHIELD surveillance program constitute the cohort for the clinical performance validation of Reccan-IA and the biomarker discovery
Exclusion criteria
Exclusion criteria: Tier 1 - eligibility assessment: 1. Refusal of consent. Tier 1 - genetic evaluation: 2. Refusal of consent. 3. Mental or other disabilities that prevent understanding and providing informed consent. Tier 2 surveillance program & sample collection: 1. Individuals receiving treatment that could affect biomarker levels. 2. Acute inflammation that could interfere with biomarker analysis (the protocol notes leaving a minimum 3-month window after end of treatment). 3. Chronic inflammation/infection, except chronic pancreatitis. 4. Prior treatment for PDAC (prior resection, radiotherapy, or chemotherapy). 5. Current immunosuppressive treatment (e.g., systemic steroid therapy or chemotherapy). 6. Systemic treatment for cancer within the last 3 months (because it could affect biomarker levels being measured). Tier 3 Validation & Biomarker Discovery No additional exclusion criteria, beyond Tier 1 and Tier 2
Countries
Belgium, Denmark, Greece, Lithuania, Slovenia, Spain, Sweden
Contacts
Public ContactIzidor;Anna Mlakar;Broden
;
Outcome results
None listed