Registry of Subjects at Risk of Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRCP, Endoultrasonography.
- Who it may be relevant to
- Registry conditions: Familial Pancreatic Cancer, BRCA1 Mutation, BRCA2 Mutation, Lynch Syndrome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Italian Registry of Families At Risk of Pancreatic Cancer
Overview
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
- 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
Primary outcome measures
- 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 [Time frame: 25 years]
Secondary outcome measures (1)
- 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 [Time frame: 25 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Istituto Clinico Humanitas — Rozzano
- Ospedale Pederzoli — Peschiera del Garda
- San Raffele Vita Salute University Hospital — Milan
- Chirurgia Generale e del Pancreas — Verona
Publications
- 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. 20 PMID 30538291
- Paiella S, Capurso G, Carrara S, Secchettin E, Casciani F, Frigerio I, Zerbi A, Archibugi L, Bonifacio C, Malleo G, Cavestro GM, Barile M, Larghi A, Assisi D, Fantin A, Milanetto AC, Fabbri C, Casadei R, Donato G, Sassatelli R, De Marchi G, Di Matteo FM, Arcangeli V, Panzuto F, Puzzono M, Dal Buono A, Pezzilli R, Salvia R, Rizzatti G, Casadio M, Franco M, Butturini G, Pasquali C, Coluccio C, Ricci PMID 37787643
Identifiers
NCT: NCT04095195 · IRFARPC