Registry of Subjects at Risk of Pancreatic Cancer

Lynch Syndrome Clinical Trial

— IRFARPC  

Official title:

Italian Registry of Families At Risk of Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095195
• Other study ID #: IRFARPC
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: September 20, 2045

Study information

• Verified date: January 2023
• Source: Associazione Italiana per lo Studio del Pancreas
• Contact: Salvatore Paiella, MD, PhD
• Phone: 00390458126009
• Email: salvatore.paiella[@]univr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 20, 2045
• Est. primary completion date: August 20, 2044
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Dysplastic Nevus Syndrome
• Familial Pancreatic Cancer
• FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome
• Hereditary Pancreatitis
• Lynch Syndrome
• Melanoma
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic
• Peutz-Jeghers Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	San Raffele Vita Salute University Hospital	Milano
Italy	Ospedale Pederzoli	Peschiera Del Garda	Verona
Italy	Istituto Clinico Humanitas	Rozzano	Milan
Italy	Chirurgia Generale e del Pancreas	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Italiana per lo Studio del Pancreas

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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