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

February 13, 2023 updated by: Associazione Italiana per lo Studio del Pancreas

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37136
        • Recruiting
        • Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Saliva testing swab
Subjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing
Genetic: Saliva swab testing
41 pancreatic cancer predisposition genes will be tested through a saliva-based swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence - absence of predisposing mutations
Time Frame: 5 years
Prevalence of genetic mutations over the total tested
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of genetic mutations with personal oncological history
Time Frame: 5 years
Correlation between presence of predisposing mutation and prevalence of cancers
5 years
Correlation of genetic mutations with familial oncological history
Time Frame: 5 years
Correlation between presence of predisposing mutation and prevalence of cancers in the family
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Anticipated)

December 20, 2027

Study Completion (Anticipated)

December 20, 2028

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPH-ITA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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