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Trial Title:
Familial Pancreatic Cancer PROPHilation Program in Italy
NCT ID:
NCT05724992
Condition:
Candidates for Hereditary Pancreatic Cancer Testing
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Cancer
Pancreatic Cancer familiarity
Genetic profiling
Genetic predisposition
Pancreatic Cancer surveillance
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Saliva swab testing
Description:
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab
Arm group label:
Saliva testing swab
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata
Address:
City:
Verona
Zip:
37136
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Salvatore Paiella, MD, PhD
Phone:
+390458126009
Email:
salvatore.paiella@univr.it
Contact backup:
Last name:
Erica Secchettin, PharmD
Phone:
+390458126254
Email:
erica.secchettin@univr.it
Start date:
December 20, 2022
Completion date:
December 20, 2028
Lead sponsor:
Agency:
Associazione Italiana per lo Studio del Pancreas
Agency class:
Other
Collaborator:
Agency:
General and Pancreatic Surgery Unit, University of Verona
Agency class:
Other
Collaborator:
Agency:
Fondazione Valsecchi
Agency class:
Other
Collaborator:
Agency:
Associazione Oltre La Ricerca
Agency class:
Other
Collaborator:
Agency:
Genomica srl
Agency class:
Other
Source:
Associazione Italiana per lo Studio del Pancreas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05724992
