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Familial Pancreatic Cancer PROPHilation Program in Italy

ConditionCandidates for Hereditary Pancreatic Cancer Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAssociazione Italiana per lo Studio del Pancreas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Saliva swab testing

    Genetic

    41 pancreatic cancer predisposition genes will be tested through a saliva-based swab

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Saliva testing swabOther 1 intervention

Trial outcomes

Primary outcomes

1

Presence - absence of predisposing mutations

Prevalence of genetic mutations over the total tested

Time frame
5 years

Secondary outcomes

1

Correlation of genetic mutations with personal oncological history

Correlation between presence of predisposing mutation and prevalence of cancers

Time frame
5 years
2

Correlation of genetic mutations with familial oncological history

Correlation between presence of predisposing mutation and prevalence of cancers in the family

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Associazione Italiana per lo Studio del Pancreas

Lead sponsor

General and Pancreatic Surgery Unit, University of Verona

Collaborator

Fondazione Valsecchi

Collaborator

Associazione Oltre La Ricerca

Collaborator

Genomica srl

Collaborator

Source ClinicalTrials.gov
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