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Registry of Subjects at Risk of Pancreatic Cancer

Italian Registry of Families At Risk of Pancreatic Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04095195
Acronym
IRFARPC
Enrollment
1000
Registered
2019-09-19
Start date
2019-08-20
Completion date
2045-09-20
Last updated
2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRCA1 Mutation, BRCA2 Mutation, Familial Pancreatic Cancer, FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome, Hereditary Pancreatitis, Lynch Syndrome, Peutz-Jeghers Syndrome

Keywords

Familial Pancreatic Cancer, BRCA Mutation, Lynch Syndrome, Screening pancreatic cancer, Surveillance pancreatic cancer

Brief 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.

Detailed 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.

Interventions

RADIATIONMRCP

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

PROCEDUREEndoultrasonography

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

Sponsors

Associazione Italiana per lo Studio del Pancreas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
This clinical study will assess the diagnostic yield of a clinical surveillance program for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals25 yearsNumber of malignant and pre-malignant lesions diagnosed over time

Secondary

MeasureTime frameDescription
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 individuals25 yearsIdentification of risk factors for malignant or pre-malignant lesions diagnosis

Countries

Italy

Contacts

Primary ContactSalvatore Paiella, MD, PhD
salvatore.paiella@univr.it00390458126009
Backup ContactSilvia Carrara, MD
silvia.carrara@humanitas.it+ 39 02 82247288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026