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Familial Pancreatic Cancer PROPHilation Program in Italy (PROPH-ITA)

Primary Purpose

Candidates for Hereditary Pancreatic Cancer Testing

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Saliva swab testing
Sponsored by
Associazione Italiana per lo Studio del Pancreas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Candidates for Hereditary Pancreatic Cancer Testing focused on measuring Pancreatic Cancer, Pancreatic Cancer familiarity, Genetic profiling, Genetic predisposition, Pancreatic Cancer surveillance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria IntegrataRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Saliva testing swab

Arm Description

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

Outcomes

Primary Outcome Measures

Presence - absence of predisposing mutations
Prevalence of genetic mutations over the total tested

Secondary Outcome Measures

Correlation of genetic mutations with personal oncological history
Correlation between presence of predisposing mutation and prevalence of cancers
Correlation of genetic mutations with familial oncological history
Correlation between presence of predisposing mutation and prevalence of cancers in the family

Full Information

First Posted
December 20, 2022
Last Updated
February 13, 2023
Sponsor
Associazione Italiana per lo Studio del Pancreas
Collaborators
General and Pancreatic Surgery Unit, University of Verona, Fondazione Valsecchi, Associazione Oltre La Ricerca, Genomica srl
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1. Study Identification

Unique Protocol Identification Number
NCT05724992
Brief Title
Familial Pancreatic Cancer PROPHilation Program in Italy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 20, 2027 (Anticipated)
Study Completion Date
December 20, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associazione Italiana per lo Studio del Pancreas
Collaborators
General and Pancreatic Surgery Unit, University of Verona, Fondazione Valsecchi, Associazione Oltre La Ricerca, Genomica srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidates for Hereditary Pancreatic Cancer Testing
Keywords
Pancreatic Cancer, Pancreatic Cancer familiarity, Genetic profiling, Genetic predisposition, Pancreatic Cancer surveillance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saliva testing swab
Arm Type
Other
Arm Description
Subjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing
Intervention Type
Genetic
Intervention Name(s)
Saliva swab testing
Intervention Description
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab
Primary Outcome Measure Information:
Title
Presence - absence of predisposing mutations
Description
Prevalence of genetic mutations over the total tested
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Correlation of genetic mutations with personal oncological history
Description
Correlation between presence of predisposing mutation and prevalence of cancers
Time Frame
5 years
Title
Correlation of genetic mutations with familial oncological history
Description
Correlation between presence of predisposing mutation and prevalence of cancers in the family
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Secchettin, PharmD
Phone
0458126254
Email
familiarita.aisp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
AISP Association
Phone
340 2713112
Email
aisp.ricerca@gmail.com
Facility Information:
Facility Name
Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata
City
Verona
ZIP/Postal Code
37136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Paiella, MD, PhD
Phone
+390458126009
Email
salvatore.paiella@univr.it
First Name & Middle Initial & Last Name & Degree
Erica Secchettin, PharmD
Phone
+390458126254
Email
erica.secchettin@univr.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Familial Pancreatic Cancer PROPHilation Program in Italy

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