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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 "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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Familial pancreatic cancer relatives |
| ||
| Peutz-Jeghers syndrome |
| ||
| 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 |
| |
| Lynch syndrome with familiarity for pancreatic cancer |
| ||
| FAMMM syndrome |
| ||
| Hereditary and genetic pancreatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRCP | Radiation | Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription |
|
| 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 |
| 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 |
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Inclusion Criteria to enter the registry:
Inclusion criteria to join the "radiologic follow-up":
Exclusion Criteria:
- pregnancy
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Subjects at high-risk of pancreatic cancer will be enrolled and a surveillance examination will be performed according to inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Paiella, MD, PhD | Contact | 00390458126009 | salvatore.paiella@univr.it | |
| Silvia Carrara, MD | Contact | + 39 02 82247288 | silvia.carrara@humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Clinico Humanitas | Recruiting | Rozzano | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30538291 | Result | 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. | |
| 37787643 |
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| Endoultrasonography | Procedure | Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist's prescription |
|
| Ospedale Pederzoli | Recruiting | Peschiera del Garda | Verona | Italy |
|
| San Raffele Vita Salute University Hospital | Recruiting | Milan | Italy |
|
| Chirurgia Generale e del Pancreas | Recruiting | Verona | 37134 | Italy |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| C535837 | Pancreatic carcinoma, familial |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D004416 | Dysplastic Nevus Syndrome |
| C537262 | Hereditary pancreatitis |
| D010580 | Peutz-Jeghers Syndrome |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009506 | Nevus |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D044483 | Intestinal Polyposis |
| D007911 | Lentigo |
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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