Registry of Subjects at Risk of Pancreatic Cancer

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04095195
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Associazione Italiana per lo Studio del Pancreas
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Familial Pancreatic Cancer, BRCA1 Mutation, BRCA2 Mutation, Lynch Syndrome, FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome, Hereditary Pancreatitis, Peutz-Jeghers Syndrome

Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Istituto Clinico Humanitas, Rozzano, Milan, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, Milan,

Site Contact

Silvia Carrara, MD

[email protected]

00390458126009

Ospedale Pederzoli, Peschiera Del Garda, Verona, Italy

Status

Recruiting

Address

Ospedale Pederzoli

Peschiera Del Garda, Verona,

Site Contact

Giovanni Butturini, MD

[email protected]

00390458126009

Milano, Italy

Status

Recruiting

Address

San Raffele Vita Salute University Hospital

Milano, ,

Site Contact

Massimo Falconi, MD

[email protected]

00390458126009

Chirurgia Generale e del Pancreas, Verona, Italy

Status

Recruiting

Address

Chirurgia Generale e del Pancreas

Verona, , 37134

Site Contact

Salvatore Paiella, MD, PhD

[email protected]

00390458126009

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