Familial Pancreatic Cancer PROPHilation Program in Italy

Not Applicable

Recruiting

• Conditions: Candidates for Hereditary Pancreatic Cancer Testing
• Interventions: Genetic: Saliva swab testing

• Registration Number: NCT05724992
• Lead Sponsor: Associazione Italiana per lo Studio del Pancreas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2022-12-20
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15
• Primary Completion: 2027-12-20
• Study Completion: 2028-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saliva testing swab	Saliva swab testing	Subjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing

Primary Outcome Measures

Name	Time	Method
Presence - absence of predisposing mutations	5 years	Prevalence of genetic mutations over the total tested

Secondary Outcome Measures

Name	Time	Method
Correlation of genetic mutations with familial oncological history	5 years	Correlation between presence of predisposing mutation and prevalence of cancers in the family
Correlation of genetic mutations with personal oncological history	5 years	Correlation between presence of predisposing mutation and prevalence of cancers

Trial Locations

Locations (1)

Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata; 🇮🇹 Verona, Italy