Pancreatic ductal adenocarcinoma (PDAC) Cancer
Conditions
Interventions
EUROPAC, although having international reach is described in relation to the UK. This national prospective observational study has been running for several decades but has been modified into the curr
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Registry: 1. Two first-degree relatives with pancreatic adenocarcinoma 2. A family with three or more relatives with pancreatic ductal adenocarcinoma. 3. Families with pancreatic cancer and other cancers (e.g. bowel, breast/ovarian, melanoma, gastric) that suggest a known cancer predisposition syndrome. 4. Families with a known inherited cancer syndrome (e.g. Hereditary Non-Polyposis Colorectal Cancer [HNPCC], familial atypical multiple mole melanoma [FAMMM], Lynch syndrome) with one individual affected by pancreatic cancer 5. Peutz-Jeghers syndrome 6. Families with a causative gene linked to pancreatic cancer (e.g. BRCA2 or yet undiscovered genes) and at least one case of pancreatic cancer in the family. 7. Families with two or more relatives with idiopathic pancreatitis. 8. Families with at least one case of pancreatitis and a confirmed causative mutation in the PRSS1 gene. Inclusion Criteria for Screening: 1. Individuals over 40 years of age from an established pancreatic cancer family. Inheritance of predisposition consistent with high penetrant autosomal dominant inheritance. For example, at least two first-degree relatives with pancreatic ductal adenocarcinoma, where no non-penetrant carriers have to be assumed over the age of 75. 2. Unaffected member of a family with an associated cancer syndrome and at least one case of pancreatic cancer, who has been shown to carry the relevant genetic alteration. 3. Any member of a hereditary pancreatitis family who has been confirmed to carry a causative PRSS1 mutation. 4. An affected member of a family consistent with HP who has tested negative for known causative PRSS1 mutations. 5. Individuals incidentally found to have cystic lesions or other clinical features that indicate an increased risk of pancreatic cancer may also be included. 6. There will be adaptation to risk models as the study progresses to fit the needs of the study outcomes as the study progresses.
Exclusion criteria
Exclusion criteria: 1. Any participant who is incapable of providing informed consent. 2. For genetic testing: Any individual who does not consent to be informed of clinically significant results. Genetic testing for a predisposition for pancreatitis will still be carried out on individuals who have expressed a wish not to be informed following detailed discussions on the limitations of a right not to know in this case; testing will be carried out only if individuals wish to have testing just for research. 3. For screening: Individuals of less than 40 years of age or 10 years younger than the youngest case in the family will be excluded. 4. For screening: Any individual deemed to have less than a 2% chance of developing PDAC in the next three years will be excluded. This will depend on the evidence supporting the models and the exclusion will only apply if the steering committee agrees on the risk assessment. A risk assessment will be made using progressively developed models. 5. For screening: Any female participant able to bear a child but who has not taken appropriate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of early-stage (stage 0, 1 or 2) pancreatic cancers found, measured at baseline CT scan and at subsequent screening investigations (yearly) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of late-stage (stage 3 or 4) pancreatic cancers found, measured at baseline CT scan and at subsequent screening investigations (yearly) 2. Number of actionable lesions found, measured at baseline CT scan and at subsequent screening investigations (yearly) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactAnnabelle Boughey
Outcome results
None listed