Registry of Subjects at Risk of Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Sep 20, 2045
  • participants needed
    1000
  • sponsor
    Associazione Italiana per lo Studio del Pancreas
Updated on 23 January 2021

Summary

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

Description

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.

Details
Condition Lentigo, Age Spots (Solar Lentigines), Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Lynch Syndrome, Peutz-Jeghers Syndrome, Hereditary Neoplastic Syndrome, Hereditary Cancer Syndromes, Dysplastic Nevus, Age Spots (Solar Lentigines), Colon Cancer Screening, Colon cancer; rectal cancer, Familial Pancreatic Cancer, Hereditary Pancreatitis, BRCA1 Mutation, BRCA2 Mutation, Hereditary Cancer Syndromes, hnpcc
Treatment MRCP, Endoultrasonography
Clinical Study IdentifierNCT04095195
SponsorAssociazione Italiana per lo Studio del Pancreas
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases
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
years for subjects suffering from FAMMM, Peutz-Jeghers syndrome

Exclusion Criteria

pregnancy
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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