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NCT Number: NCT05724992

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.

Recruiting

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Key information

Conditions

Candidates for Hereditary Pancreatic Cancer Testing Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Susceptibility Endocrine Gland Neoplasms Endocrine System Diseases Genetic Predisposition to Disease Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saliva swab testing

Genetic

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

Primary outcomes

  1. Presence - absence of predisposing mutations

    Time frame: 5 years

    Prevalence of genetic mutations over the total tested

Secondary outcomes

  1. Correlation of genetic mutations with personal oncological history

    Time frame: 5 years

    Correlation between presence of predisposing mutation and prevalence of cancers

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

AISP Association

CONTACT

[email protected]

340 2713112

Erica Secchettin, PharmD

CONTACT

[email protected]

0458126254

Sponsors and collaborators

Lead sponsor

Associazione Italiana per lo Studio del Pancreas

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PROPH-ITA

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 13, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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