Registry Of Subjects At Risk Of Pancreatic Cancer

Study Overview

Registry of Subjects at Risk of Pancreatic Cancer

IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.

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 Ȯnrollment 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.

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

IRFARPC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-09-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-01-12
First Submitted that Met QC Criteria 2019-09-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-01-13
First Posted (ACTUAL) 2019-09-19	Results First Posted N/A	Last Verified 2023-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
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	Number of malignant and pre-malignant lesions diagnosed over time	25 years

Secondary Outcome Measures	Measure Description	Time Frame
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	Identification of risk factors for malignant or pre-malignant lesions diagnosis	25 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Salvatore Paiella, MD, PhD

Phone Number: 00390458126009

Email: salvatore.paiella@univr.it

Study Contact Backup

Name: Silvia Carrara, MD

Phone Number: + 39 02 82247288

Email: silvia.carrara@humanitas.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. 2019 Apr;114(4):665-670. doi: 10.1038/s41395-018-0414-z.
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 C, Cicchese N, Sereni G, de Pretis N, Stigliano S, Rudnas B, Marasco M, Lionetto G, Arcidiacono PG, Terrin M, Crovetto A, Mannucci A, Laghi L, Bassi C, Falconi M. Outcomes of a 3-Year Prospective Surveillance in Individuals at High Risk of Pancreatic Cancer. Am J Gastroenterol. 2024 Apr 1;119(4):739-747. doi: 10.14309/ajg.0000000000002546. Epub 2023 Oct 3.

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