Pancreatic cancer, pancreatic cancer high-risk patients
Conditions
Interventions
None listed
Sponsors
Craif Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pancreatic Cancer Patients: To qualify for this study, individuals must meet criteria (1) through (5): (1) Japanese nationals aged 18 years or older at the time of signing the consent form. (2) Written consent, approved by the Ethical Review Committee of the respective research institution, can be obtained from the individual or their surrogate, based on their free will. (3) Diagnosis of invasive pancreatic ductal carcinoma (PDAC) or suspected intraductal papillary mucinous carcinoma (IPMC) with scheduled surgery. (4) Blood samples collected within the past 90 days used to measure CA19-9. (5) No prior treatment for invasive PDAC or suspected IPMC at the time of consent. Non-Pancreatic Cancer (Pancreatic Cancer High-Risk) Patients: To be eligible for this study, individuals must meet criteria (1) through (4): (1) Japanese nationals aged 18 years or older at the time of signing the consent form. (2) Written consent, based on their or their surrogate's free will, using an approved consent document from the Ethical Review Committee of the respective research institution. (3) Imaging studies ruling out pancreatic cancer or pathology confirming the absence of pancreatic cancer. (4) Presence of high-risk factors for pancreatic cancer: type 2 diabetes mellitus, chronic pancreatitis, family history of pancreatic cancer, intraductal papillary mucinous neoplasm (IPMN), pancreatic cyst, or pancreatic duct dilation. Healthy Volunteers: To participate in this study, individuals must meet criteria (1) through (3): (1) Japanese nationals aged 50 years or older at the time of signing the consent form. (2) Able to provide written consent willingly using an approved consent document from the Ethical Review Committee of the respective research institution. (3) Assessed by a physician to be in good health based on medical evaluation, including history, physical examination, vital signs, and laboratory values.
Exclusion criteria
Exclusion criteria: At the time of obtaining consent, individuals who meet any of the following criteria (1) to (5) will not be included in this study. However, for healthy adults, criterion (3) will be defined as "individuals with a history of malignant tumors." (1) Patients with severe renal failure or other conditions that make it difficult to urinate independently, such as requiring assistance with urination. (2) Pregnant individuals or those with a possibility of pregnancy. (3) Individuals with other active malignant tumors (currently undergoing treatment or within 5 years of treatment completion). (4) Individuals currently participating in other interventional trials (including clinical trials) outside of this study. (5) Other individuals deemed inappropriate by the study institution's physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Using the predictive model or biomarker constructed to classify pancreatic cancer and non-pancreatic cancer (pancreatic cancer high-risk) groups, the following will be evaluated. (1) Sensitivity, specificity, positive predictive value, negative predictive value, and positive diagnostic value for pancreatic cancer (2) Sensitivity to pancreatic cancer by stage (3) Sensitivity to pancreatic cancer by tumor size (4) Comparison with sensitivity, specificity, positive predictive value, negative predictive value, and positive diagnostic value of each test item (including imaging tests) in the participants of this study (5) Comparison with the sensitivity and specificity of each test item (including imaging tests) in previous reports (6) Sensitivity, specificity, and positive predictive value for pancreatic cancer in multiple prediction models (7) Sensitivity, specificity, and positive diagnostic rate for pancreatic cancer in each of the other subpopulations (8) Sensitivity, specificity, and positive diagnostic rate for pancreatic cancer when combined with other test items | — |
Countries
Japan
Contacts
Public ContactMotoki Mikami
Craif inc. Clinical Development
Outcome results
None listed