NCT04095195

Registry of Subjects at Risk of Pancreatic Cancer

Italian Registry of Families At Risk of Pancreatic Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Associazione Italiana per lo Studio del Pancreas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	MRCP	Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription
PROCEDURE	Endoultrasonography	Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription

Timeline

• Start date: 2019-08-20
• Primary completion: 2044-08-20
• Completion: 2045-09-20
• First posted: 2019-09-19
• Last updated: 2023-01-13

Locations

4 sites across 1 country: Italy