Familial Pancreatic Cancer PROPHilation Program in Italy

NCT ID: NCT05724992

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2028-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Candidates for Hereditary Pancreatic Cancer Testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Saliva swab testing

Intervention Type GENETIC

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

Interventions

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Saliva swab testing

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General and Pancreatic Surgery Unit, University of Verona

UNKNOWN

Sponsor Role collaborator

Fondazione Valsecchi

UNKNOWN

Sponsor Role collaborator

Associazione Oltre La Ricerca

UNKNOWN

Sponsor Role collaborator

Genomica srl

UNKNOWN

Sponsor Role collaborator

Associazione Italiana per lo Studio del Pancreas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Erica Secchettin, PharmD

Role: CONTACT

0458126254

AISP Association

Role: CONTACT

340 2713112

Facility Contacts

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Salvatore Paiella, MD, PhD

Role: primary

+390458126009

Erica Secchettin, PharmD

Role: backup

+390458126254

Other Identifiers

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PROPH-ITA

Identifier Type: -

Identifier Source: org_study_id

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