pancreatic cancer high-risk patients
Conditions
Interventions
None listed
Sponsors
Craif Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese who are 40 years of age or older on the date of signing the consent form. 2) Persons who are able to obtain written consent for participation in this study of their own free will from the Institute, using a consent document approved by the Ethical Review Committee, etc. of each research institution. 3) Those who have one or more of the following high-risk factors for pancreatic cancer. (1) Patients who have been treated for any of the following diseases or co-morbidities. Type 2 diabetes, chronic pancreatitis, family history of pancreatic cancer (at least one parent, child, or sibling who is a first-degree relative has a history of pancreatic cancer), IPMN, pancreatic cyst, pancreatic duct dilation 4) Those who can expect regular visits to the hospital (at least once every 6 months) for at least the next 1 year.
Exclusion criteria
Exclusion criteria: 1) Patients who have difficulty urinating on their own due to severe renal failure or need nursing care to urinate. 2) Women who are currently pregnant, may become pregnant, or plan to become pregnant within the next year. 3)Currently diagnosed with a malignancy or have a history of malignancy within the past 5 years. 4)Are currently participating in an interventional trial (including clinical trials) other than this study or plan to participate in an interventional trial (including clinical trials) in the next 1 year. 5) Any other person who is deemed inappropriate by the investigator of the research institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will measure miRNA profiles and DNA methylation profiles from the specimens collected in this study. The correlation between these profiles and clinical information, such as changes in the condition of high-risk pancreatic cancer patients (including the onset of pancreatic cancer), will be evaluated over the follow-up period. In especially cases where the development of pancreatic cancer is confirmed during the follow-up period, changes in miRNA profiles leading up to the development of pancreatic cancer will be analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, we will apply the classification model for pancreatic cancer diagnosis, including early stages, which was constructed using machine learning of miRNA profiles in previous joint research by Craif Inc. We will evaluate the correlation between the judgment results of this classification model and clinical information. | — |
Countries
Japan
Contacts
Public ContactMotoki Mikami
Craif Inc. Clinical Development and Regulatory Affiars
Outcome results
None listed