Familial Pancreatic Cancer PROPHilation Program in Italy

Candidates for Hereditary Pancreatic Cancer Testing Clinical Trial

— PROPH-ITA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724992
• Other study ID #: PROPH-ITA
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: December 20, 2028

Study information

• Verified date: February 2023
• Source: Associazione Italiana per lo Studio del Pancreas
• Contact: Erica Secchettin, PharmD
• Phone: 0458126254
• Email: familiarita.aisp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 20, 2028
• Est. primary completion date: December 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidates for Hereditary Pancreatic Cancer Testing
• Pancreatic Neoplasms

Intervention

Genetic:
• Saliva swab testing
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab

Locations

Country	Name	City	State
Italy	Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata	Verona

Sponsors (5)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence - absence of predisposing mutations	Prevalence of genetic mutations over the total tested	5 years
Secondary	Correlation of genetic mutations with personal oncological history	Correlation between presence of predisposing mutation and prevalence of cancers	5 years
Secondary	Correlation of genetic mutations with familial oncological history	Correlation between presence of predisposing mutation and prevalence of cancers in the family	5 years