Clinical trial NCT04095195: Registry of Subjects at Risk of Pancreatic Cancer
Official title: Italian Registry of Families At Risk of Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Familial Pancreatic Cancer
BRCA1 Mutation
BRCA2 Mutation
Lynch Syndrome
FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome
Hereditary Pancreatitis
Peutz-Jeghers Syndrome
Keywords: Familial Pancreatic Cancer
BRCA Mutation
Lynch Syndrome
Screening pancreatic cancer
Surveillance pancreatic cancer
Lead sponsor: Associazione Italiana per lo Studio del Pancreas
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects at high-risk of pancreatic cancer will be enrolled and a surveillance examination will be performed according to inclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 25 years
Secondary outcomes:
measure: 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
timeFrame: 25 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
city: Peschiera Del Garda
country: Italy
facility: Ospedale Pederzoli
state: Verona
city: Milano
country: Italy
facility: San Raffele Vita Salute University Hospital
city: Verona
country: Italy
facility: Chirurgia Generale e del Pancreas
Study officials:
References:
citation: Paiella S, Capurso G, Cavestro GM, Butturini G, Pezzilli R, Salvia R, Signoretti M, Crippa S, Carrara S, Frigerio I, Bassi C, Falconi M, Iannicelli E, Giardino A, Mannucci A, Laghi A, Laghi L, Frulloni L, Zerbi A. Results of First-Round of Surveillance in Individuals at High-Risk of Pancreatic Cancer from the AISP (Italian Association for the Study of the Pancreas) Registry. Am J Gastroenterol. 2019 Apr;114(4):665-670. doi: 10.1038/s41395-018-0414-z.