Familial Pancreatic Cancer PROPHilation Program in Italy
PROPH-ITA
Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer
1 other identifier
interventional
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2022
CompletedStudy Start
First participant enrolled
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2028
February 15, 2023
February 1, 2023
5 years
December 20, 2022
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence - absence of predisposing mutations
Prevalence of genetic mutations over the total tested
5 years
Secondary Outcomes (2)
Correlation of genetic mutations with personal oncological history
5 years
Correlation of genetic mutations with familial oncological history
5 years
Study Arms (1)
Saliva testing swab
OTHERSubjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing
Interventions
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Already known genetic mutation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Associazione Italiana per lo Studio del Pancreaslead
- General and Pancreatic Surgery Unit, University of Veronacollaborator
- Fondazione Valsecchicollaborator
- Associazione Oltre La Ricercacollaborator
- Genomica srlcollaborator
Study Sites (1)
Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata
Verona, 37136, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2022
First Posted
February 13, 2023
Study Start
December 20, 2022
Primary Completion (Estimated)
December 20, 2027
Study Completion (Estimated)
December 20, 2028
Last Updated
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share