IRFARPC: Registry of Subjects at Risk of Pancreatic Cancer

Sponsor

Associazione Italiana per lo Studio del Pancreas (Other)

Overall Status

Recruiting

CT.gov ID

NCT04095195

Collaborator

(none)

1,000

Enrollment

Locations

313

Anticipated Duration (Months)

250

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Familial Pancreatic Cancer BRCA1 Mutation BRCA2 Mutation Lynch Syndrome FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome Hereditary Pancreatitis Peutz-Jeghers Syndrome	Radiation: MRCP Procedure: Endoultrasonography

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Italian Registry of Families At Risk of Pancreatic Cancer

Actual Study Start Date :

Aug 20, 2019

Anticipated Primary Completion Date :

Aug 20, 2044

Anticipated Study Completion Date :

Sep 20, 2045

Arms and Interventions

Arm	Intervention/Treatment
Familial pancreatic cancer relatives	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
Peutz-Jeghers syndrome	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
BRCA 1/2, PALB2, p16 mutations with familiarity for PC Known genetic mutation and at least 1 1st- or 2nd-degree relative suffering from PC	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
Lynch syndrome with familiarity for pancreatic cancer	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
FAMMM syndrome	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
Hereditary and genetic pancreatitis	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

Outcome Measures

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 [25 years]

Secondary Outcome Measures

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]

Other Outcome Measures

The psychological burden of a surveillance program for pancreatic cancer will be assessed [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Rozzano	Milan	Italy
2	Ospedale Pederzoli	Peschiera Del Garda	Verona	Italy
3	San Raffele Vita Salute University Hospital	Milano		Italy
4	Chirurgia Generale e del Pancreas	Verona		Italy	37134