Registry of Subjects at Risk of Pancreatic Cancer
- Conditions
- Peutz-Jeghers SyndromeFamilial Pancreatic CancerBRCA2 MutationHereditary PancreatitisFAMMM - Familial Atypical Mole Malignant Melanoma SyndromeBRCA1 MutationLynch Syndrome
- Interventions
- Radiation: MRCPProcedure: Endoultrasonography
- Registration Number
- NCT04095195
- Lead Sponsor
- Associazione Italiana per lo Studio del Pancreas
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Familial pancreatic cancer relatives Endoultrasonography - Familial pancreatic cancer relatives MRCP - BRCA 1/2, PALB2, p16 mutations with familiarity for PC Endoultrasonography Known genetic mutation and at least 1 1st- or 2nd-degree relative suffering from PC Lynch syndrome with familiarity for pancreatic cancer Endoultrasonography - Lynch syndrome with familiarity for pancreatic cancer MRCP - Hereditary and genetic pancreatitis MRCP - FAMMM syndrome MRCP - Hereditary and genetic pancreatitis Endoultrasonography - BRCA 1/2, PALB2, p16 mutations with familiarity for PC MRCP Known genetic mutation and at least 1 1st- or 2nd-degree relative suffering from PC Peutz-Jeghers syndrome MRCP - Peutz-Jeghers syndrome Endoultrasonography - FAMMM syndrome Endoultrasonography -
- Primary Outcome Measures
Name Time Method 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 25 years Number of malignant and pre-malignant lesions diagnosed over time
- Secondary Outcome Measures
Name Time Method 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 25 years Identification of risk factors for malignant or pre-malignant lesions diagnosis
Trial Locations
- Locations (4)
Chirurgia Generale e del Pancreas
🇮🇹Verona, Italy
San Raffele Vita Salute University Hospital
🇮🇹Milano, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Milan, Italy
Ospedale Pederzoli
🇮🇹Peschiera Del Garda, Verona, Italy