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Clinical Trials/NCT05724992
NCT05724992
Recruiting
Not Applicable

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

Associazione Italiana per lo Studio del Pancreas1 site in 1 country3,000 target enrollmentDecember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Candidates for Hereditary Pancreatic Cancer Testing
Sponsor
Associazione Italiana per lo Studio del Pancreas
Enrollment
3000
Locations
1
Primary Endpoint
Presence - absence of predisposing mutations
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2022
End Date
December 20, 2028
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Associazione Italiana per lo Studio del Pancreas
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Presence - absence of predisposing mutations

Time Frame: 5 years

Prevalence of genetic mutations over the total tested

Secondary Outcomes

  • Correlation of genetic mutations with familial oncological history(5 years)
  • Correlation of genetic mutations with personal oncological history(5 years)

Study Sites (1)

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