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Familial Pancreatic Cancer PROPHilation Program in Italy

Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05724992
Acronym
PROPH-ITA
Enrollment
3000
Registered
2023-02-13
Start date
2022-12-20
Completion date
2028-12-20
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidates for Hereditary Pancreatic Cancer Testing

Keywords

Pancreatic Cancer, Pancreatic Cancer familiarity, Genetic profiling, Genetic predisposition, Pancreatic Cancer surveillance

Brief summary

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

GENETICSaliva swab testing

41 pancreatic cancer predisposition genes will be tested through a saliva-based swab

Sponsors

General and Pancreatic Surgery Unit, University of Verona
CollaboratorUNKNOWN
Fondazione Valsecchi
CollaboratorUNKNOWN
Associazione Oltre La Ricerca
CollaboratorUNKNOWN
Genomica srl
CollaboratorUNKNOWN
Associazione Italiana per lo Studio del Pancreas
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence - absence of predisposing mutations5 yearsPrevalence of genetic mutations over the total tested

Secondary

MeasureTime frameDescription
Correlation of genetic mutations with personal oncological history5 yearsCorrelation between presence of predisposing mutation and prevalence of cancers
Correlation of genetic mutations with familial oncological history5 yearsCorrelation between presence of predisposing mutation and prevalence of cancers in the family

Countries

Italy

Contacts

Primary ContactErica Secchettin, PharmD
familiarita.aisp@gmail.com0458126254
Backup ContactAISP Association
aisp.ricerca@gmail.com340 2713112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026