Familial Pancreatic Cancer PROPHilation Program in Italy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saliva swab testing.
- Who it may be relevant to
- Registry conditions: Candidates for Hereditary Pancreatic Cancer Testing. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer
Overview
The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only. Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test. Up to 3,000 participants will be enrolled in this study.
Interventions
- Genetic Saliva swab testing
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab
Primary outcome measures
- Presence - absence of predisposing mutations [Time frame: 5 years]
Secondary outcome measures (2)
- Correlation of genetic mutations with personal oncological history [Time frame: 5 years]
- Correlation of genetic mutations with familial oncological history [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Being enrolled on the IRFARPC registry
- Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)
- Willingness to participate in saliva-swab-based genetic testing
Exclusion criteria
\- Already known genetic mutation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata — Verona
Publications
- Paiella S, Secchettin E, Archibugi L, De Luca R, Bonifacio C, Laghi L, Lionetto G, Milanetto AC, Sereni G, Coluccio C, Lauri G, Dal Buono A, Patruno M, Gabriel G, Sassatelli R, Binda C, Bonvissuto D, Uliana V, Malleo G, Cavestro GM, Terrin M, Martino S, Pasquali C, De Pastena M, De Cobelli F, Poletti V, Venturini E, Puzzono M, Zerbi A, Arcidiacono PG, Salvia R, Falconi M, Capurso G, Carrara S. Dis PMID 41691430
Identifiers
NCT: NCT05724992 · PROPH-ITA