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NCT Number: NCT04095195

Registry of Subjects at Risk of Pancreatic Cancer

IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.

Recruiting

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Key information

About this study

Pancreatic cancer is a devastating disease with a dismal prognosis. One of the ways to improve survival might be early detection.

Within years, many predisposing diseases or genetic conditions have been identified, thus screening/surveillance have been established worldwide.

A registry of subjects at risk of pancreatic cancer will has been built up to investigate the possibility of diagnosis pancreatic cancer, or one if its predisposing lesions.

Inclusion criteria

will be adopted as "enrollment criteria". According to this, individuals > 18 years old will be enrolled; their familiar history and/or genetic predisposition will be collected, as well as current or previous medical records/medications data. Thereafter, according to specific age-based criteria, those individuals initially enrolled will be will be considered for a "surveillance protocol" ("interventional follow-up criteria") and they will be submitted to Cholangio-Wirsung Magnetic Resonance or Pancreatic Endoultrasonography according to the pancreatologist's prescription at each participating center.

Individuals suffering from the following conditions will be enrolled:

familial pancreatic cancer; Peutz-Jeghers syndrome; a known BRCA-2, BRCA-1, PALB2, or p16 mutation with at least one first- or second-degree relative suffering from pancreatic cancer; hereditary pancreatitis; FAMMM syndrome; Lynch syndrome with at least one first- or second-degree relative suffering from pancreatic cancer.

Who can participate

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

Inclusion criteria

to enter the registry:

  • individuals with at least two relatives suffering from pancreatic cancer, with at least 1 first-degree and until the third-degree
  • subjects with known genetic mutation of BRCA2, BRCA1, p16, PALB2 with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer
  • subjects suffering from FAMMM Syndrome
  • subjects suffering from Peutz-Jeghers Syndrome
  • subjects suffering from PRSS-1- or CFTR- or SPINK-1- related pancreatitis
  • subjects suffering from Lynch syndrome with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer

Inclusion criteria

to join the "radiologic follow-up":

  • 45 years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases
  • 40 years or 5 years younger than the youngest index case of pancreatic cancer for subjects suffering from hereditary/genetic pancreatitis, Lynch syndrome, or carrying a known BRCA 1/2, PALB2, p16 genetic mutation with familiarity for pancreatic cancer
  • 30 years for subjects suffering from FAMMM, Peutz-Jeghers syndrome

Exclusion criteria

  • pregnancy

Treatment and study plan

MRCP

Radiation

Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription

Endoultrasonography

Procedure

Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription

Primary outcomes

  1. This clinical study will assess the diagnostic yield of a clinical surveillance program for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals

    Time frame: 25 years

    Number of malignant and pre-malignant lesions diagnosed over time

Secondary outcomes

  1. This study will investigate possible risk factors for the incidence or the progression of for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals

    Time frame: 25 years

    Identification of risk factors for malignant or pre-malignant lesions diagnosis

Study contacts

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

Salvatore Paiella, MD, PhD

CONTACT

[email protected]

00390458126009

Silvia Carrara, MD

CONTACT

[email protected]

+ 39 02 82247288

Sponsors and collaborators

Lead sponsor

Associazione Italiana per lo Studio del Pancreas

Other

Registry information

Official study title

Italian Registry of Families At Risk of Pancreatic Cancer

Acronym: IRFARPC

Important dates

Study start
2019
Primary completion
2044
Study completion
2045
First posted
Sep 19, 2019
Registry last updated
Jan 13, 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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