Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry of Subjects at Risk of Pancreatic Cancer (IRFARPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095195
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Associazione Italiana per lo Studio del Pancreas

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
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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian Registry of Families At Risk of Pancreatic Cancer
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : August 20, 2044
Estimated Study Completion Date : September 20, 2045


Group/Cohort 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 :
  1. 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 ]

Other Outcome Measures:
  1. The psychological burden of a surveillance program for pancreatic cancer will be assessed [ Time Frame: 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095195


Contacts
Layout table for location contacts
Contact: Salvatore Paiella, MD, PhD 00390458126009 salvatore.paiella@univr.it
Contact: Silvia Carrara, MD + 39 02 82247288 silvia.carrara@humanitas.it

Locations
Layout table for location information
Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milan, Italy
Contact: Silvia Carrara, MD       silvia.carrara@humanitas.it   
Principal Investigator: Alessandro Zerbi, MD         
Principal Investigator: Luigi Laghi, MD, PhD         
Sub-Investigator: Laura Poliani, MD         
Sub-Investigator: Valentina Giatti         
Ospedale Pederzoli Recruiting
Peschiera Del Garda, Verona, Italy
Contact: Giovanni Butturini, MD         
Sub-Investigator: Alessandro Giardino, MD, PhD         
Sub-Investigator: Isabella Frigerio, MD, PhD         
San Raffele Vita Salute University Hospital Recruiting
Milano, Italy
Contact: Massimo Falconi, MD       massimo.falconi@hsr.it   
Principal Investigator: Gabriele Capurso, MD, PhD         
Sub-Investigator: Silvia Smaniotto         
Chirurgia Generale e del Pancreas Recruiting
Verona, Italy, 37134
Contact: Salvatore Paiella, MD, PhD    00390458126009    salvatore.paiella@univr.it   
Contact: Erica Secchettin, PharmD    00390458126254    erica.secchettin@univr.it   
Principal Investigator: Salvatore Paiella, MD, PhD         
Principal Investigator: Giuseppe Malleo, MD, PhD         
Principal Investigator: Claudio Bassi, MD         
Principal Investigator: Roberto Salvia, MD, PhD         
Sub-Investigator: Erica Secchettin, PharmD         
Sub-Investigator: Veronica Marinelli, PhD         
Sponsors and Collaborators
Associazione Italiana per lo Studio del Pancreas

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Associazione Italiana per lo Studio del Pancreas
ClinicalTrials.gov Identifier: NCT04095195     History of Changes
Other Study ID Numbers: IRFARPC
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Associazione Italiana per lo Studio del Pancreas:
Familial Pancreatic Cancer
BRCA Mutation
Lynch Syndrome
Screening pancreatic cancer
Surveillance pancreatic cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Neoplastic Syndromes, Hereditary
Melanoma
Peutz-Jeghers Syndrome
Dysplastic Nevus Syndrome
Pancreatitis
Pancreatitis, Chronic
Syndrome
Disease
Pathologic Processes
Nevi and Melanomas
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases