Pancreatic cancer, lung cancer, breast cancer, colorectal cancer, gastric cancer, esophageal cancer, ovarian cancer, kidney cancer, urothelial cancer, prostate cancer, cervical cancer, uterine cancer, liver cancer, gallbladder and bile duct cancer, head and neck cancer, hematological malignancies
Conditions
Interventions
None listed
Sponsors
Craif Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [For cancer patients] To participate in this study, you must meet all of the following criteria (1) through (4). (1) Be 18 years of age or older as of the date of signing the consent form. (2) The patient is able to obtain written consent for participation in this study based on the free will of the patient or a surrogate, using a consent document approved by the Ethical Review Committee of the respective research institution. (3) The patient has been diagnosed with one of the following cancers, the primary site of which is known. The histological type and stage of the cancer are not questioned. Pancreatic cancer, lung cancer, breast cancer, colorectal cancer, stomach cancer, esophageal cancer, ovarian cancer, kidney cancer, urothelial carcinoma, prostate cancer, cervical cancer, uterine cancer, liver cancer, gallbladder and bile duct cancer, head and neck cancer (any site), hematopoietic tumor (malignant lymphoma, leukemia, multiple myeloma) (4) There is no history of treatment for cancer at the time the urine specimen is collected. [For healthy adults] To participate in this study, you must meet all of the following criteria (1) through (3). (1) Japanese nationals who are between 40 and 90 years of age on the date of signing the consent form. (2) The individual or surrogate is able to obtain written consent for participation in this study based on his/her own free will using a consent document approved by the ethics review committee of the respective research institution, etc. (3) Persons who are judged by a physician to be in good health based on a medical evaluation including history, physical examination, vital signs (blood pressure, pulse rate), and clinical laboratory values.
Exclusion criteria
Exclusion criteria: Persons who meet any of the following criteria (1) through (6) at the time of specimen collection will not be included in this study. (1) Women who are pregnant or may become pregnant. (2) Women who are menstruating at the time of scheduled urine sample collection. (3) Those with a history of malignancy within the past 5 years. (4) Patients with multiple cancers whose primary tumor is located in more than one organ. (5) Who are currently participating in an interventional study (including a clinical trial) other than this study. (6) Any other person who is deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) miRNA expression level or (2) DNA methylation rate will be measured and the performance of the prediction model constructed by machine learning using these as features will be evaluated. The diagnostic performance for each cancer type will be evaluated based on statistics such as AUC value, sensitivity and specificity. As other biomarkers in urine are still in the exploratory stage, specific evaluation will be conducted from the setting of specific evaluation contents. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study is a non-interventional clinical research, and there are no health risks to the study participants. Therefore, no information regarding safety is collected. | — |
Countries
Japan
Contacts
Public ContactMotoki Mikami
Craif Inc. Clinical Development
Outcome results
None listed