Registry for people at risk of pancreatic cancer
Italian Registry of Families At Risk of Pancreatic Cancer
This study is collecting information from people at risk of pancreatic cancer due to family history or genetic factors to see if regular check-ups can help catch the disease early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Associazione Italiana per lo Studio del Pancreas Academic / other |
| Locations | 4 sites (Rozzano, Milan and 3 other locations) |
| Trial ID | NCT04095195 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect data on individuals with inherited risks for pancreatic cancer, including those with familial pancreatic cancer and specific genetic mutations like BRCA1 and BRCA2. Participants over 18 years old will have their family history and medical records documented, and based on their risk factors, they may undergo surveillance procedures such as Magnetic Resonance Cholangiopancreatography (MRCP) or Endoultrasonography. The goal is to improve early detection and diagnosis of pancreatic cancer or its predisposing lesions through systematic screening.
Who should consider this trial
Good fit: Ideal candidates include individuals with a family history of pancreatic cancer or known genetic mutations associated with increased risk.
Not a fit: Patients without a family history of pancreatic cancer or those without the specified genetic predispositions may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could lead to earlier diagnosis and improved survival rates for patients at high risk of pancreatic cancer.
How similar studies have performed: Other studies focusing on genetic predispositions and early detection of pancreatic cancer have shown promise, indicating that this approach is supported by previous findings.
Eligibility criteria
Show full 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
Where this trial is running
Rozzano, Milan and 3 other locations
- Istituto Clinico Humanitas — Rozzano, Milan, Italy (Recruiting)
- Ospedale Pederzoli — Peschiera del Garda, Verona, Italy (Recruiting)
- San Raffele Vita Salute University Hospital — Milan, Italy (Recruiting)
- Chirurgia Generale e del Pancreas — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Salvatore Paiella, MD, PhD
- Email: salvatore.paiella@univr.it
- Phone: 00390458126009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.