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Familial Pancreatic Cancer PROPHilation Program in Italy


2022-12-20


2027-12-20


2028-12-20


3000

Study Overview

Familial Pancreatic Cancer PROPHilation Program in Italy

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.

N/A

  • Candidates for Hereditary Pancreatic Cancer Testing
  • GENETIC: Saliva swab testing
  • PROPH-ITA

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 Registration Dates Results Reporting Dates Study Record Updates

2022-12-20  

N/A  

2023-02-13  

2023-02-02  

N/A  

2023-02-15  

2023-02-13  

N/A  

2023-02  

Study Plan

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

Design Details

Primary Purpose:
Other


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Presence - absence of predisposing mutationsPrevalence of genetic mutations over the total tested5 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Correlation of genetic mutations with personal oncological historyCorrelation between presence of predisposing mutation and prevalence of cancers5 years
Correlation of genetic mutations with familial oncological historyCorrelation between presence of predisposing mutation and prevalence of cancers in the family5 years

Contacts and Locations

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

Study Contact

Name: Erica Secchettin, PharmD

Phone Number: 0458126254

Email: familiarita.aisp@gmail.com

Study Contact Backup

Name: AISP Association

Phone Number: 340 2713112

Email: aisp.ricerca@gmail.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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

Collaborators and Investigators

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

  • General and Pancreatic Surgery Unit, University of Verona
  • Fondazione Valsecchi
  • Associazione Oltre La Ricerca
  • Genomica srl

  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available