Histologically confirmed solid tumors or malignant lymphomas, with a focus on the 16 types of cancer with particularly high incidence rates in Japan (lung, stomach, prostate, colorectal, breast, liver, pancreas, bladder, renal pelvis, esophagus, kidney, endometrial, cervical, ovarian, biliary tract, and head and neck).
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital East
Exact Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All Cohorts 1. Participants must be between 45 and 84 years of age at the time of consent. 2. Participants must understand the study protocol and have provided written informed consent to participate in this study. 3. Participants must be of Japanese descent or Japanese nationals residing in Japan. 4. Participants must be able to provide a peripheral blood sample for this study. Non-Cancer Cohort Only 5. Based on self-reports, it can be confirmed that participants have undergone the screening recommended by Japan's cancer screening programs for gastric cancer, colorectal cancer, lung cancer, breast cancer, and cervical cancer. Taking into account variations in gender, age, and the timing of screening, the criteria for each cancer type are defined as follows. a. Gastric cancer: For men and women aged 50 and older, they must have undergone an upper gastrointestinal X-ray or gastroscopy within the past 30 months. For men and women aged 45 to 49, they must have undergone an upper gastrointestinal X-ray within the past 15 months. b. Colorectal cancer: For men and women aged 45 and older, they must have undergone a fecal occult blood test (immunoassay) within the past 15 months. c. Lung cancer: For men and women aged 45 and older, a chest X-ray must have been performed within the past 15 months. d. Breast cancer: For women aged 45 and older, a mammogram must have been performed within the past 30 months. e. Cervical cancer: For women aged 45 and older, a cervical cytology test must have been performed within the past 30 months. 6. You do not plan to leave Japan to take up permanent residence in another country within 12 months of the blood sample collection. 7. You are willing to confirm that you remain cancer-free approximately 12 months after the blood sample collection. Cancer Cohort Only 8. You have a suspected cancer or have been diagnosed with cancer.
Exclusion criteria
Exclusion criteria: All cohorts 1. Received chemotherapy and/or radiation therapy for any medical condition within 5 years prior to enrollment. 2. Underwent core needle biopsy or puncture aspiration cytology for any reason within 3 days prior to blood sample collection. 3. Underwent an incisional or excisional biopsy for any reason within 7 days prior to blood sample collection. 4. The principal investigator determines that the participant is inappropriate for this study. 5. Have an infectious disease with fever at the time of blood collection. 6. Have a history of allogeneic bone marrow transplantation, stem cell transplantation, or solid organ transplantation, or is scheduled to undergo such transplantation prior to blood sample collection. 7. Current primary diagnosis of stage 0, intraepithelial carcinoma (including DCIS and LCIS). Cancer cohort only 8.Have a history of cancer, including solid tumors or hematologic malignancies. However, if the cancer was treated and has not recurred for more than 5 years after treatment, it is not included in the history of cancer as an exclusion criterion. 9. Concurrent diagnosis of multiple (newly diagnosed) primary cancers. 10. Have hematologic malignancies other than malignant lymphoma. 11. Current primary diagnosis of non-invasive basal cell carcinoma or squamous cell carcinoma. 12. Local or systemic anti-cancer therapy for the newly diagnosed cancer (e.g., surgical resection, radiation therapy, and/or systemic anticancer therapy including chemotherapy, endocrine therapy, immunotherapy, molecular targeted therapy, or other biological control) has been initiated or will be initiated before the blood sample is collected. Non-cancer cohort only 13. Have a history of cancer, including solid tumors or hematologic cancers. 14. Clinically suspected active malignancy. 15. Positive screening test result for cancer (confirmed or unconfirmed on close examination) within 3 years prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the overall sensitivity(across all cancer types and stages) and specificity for the Exact Sciences' MCED test . | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the sensitivity for the Exact Sciences' MCED test for subgroups including, but not limited to: individual, cancer type, clinical stage, and individual cancer type and stage. | — |
Countries
Japan
Contacts
Public ContactTakeaki Yamazaki
National Cancer Center Hospital East Department of Gastroenterology and Endoscopy
Outcome results
None listed