Colorectal cancer and advanced adenoma.
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. >= 20 years of age at the time of enrollment. 2. Confirmed as either of the following a-f by colonoscopy within 60 days before the enrollment. a. Advanced colorectal adenoma (>= 10mm adenoma) b. Clinical stage 0 (TisN0M0 c. Clinical stage I (T1-2N0M0) d. Clinical stage IIA (T3N0M0) e. Clinical stage IIB (T4aN0M0) f. Clinical stage IIC (T4bN0M0) 3. Planned a resection for the colorectal cancer or advanced adenoma in the eligibility criteria #2. 4. Willing to provide blood samples per protocol. 5. Has given written consent.
Exclusion criteria
Exclusion criteria: 1. Have previous history of cancer, including colorectal cancer, within 10 years before the enrollment. 2. Have previous history of colorectal advanced adenoma within 3 months before the enrollment. 3. Are suspected to have other malignancies by chest-abdomen-pelvic contrast CT within 60 days before the enrollment. 4. Are pregnant. 5. Are judged by the study doctor to be ineligible for the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive rate of LUNAR assay in advanced colorectal adenoma and stage 0-2 colorectal cancer. | — |
Countries
Japan
Contacts
National Cancer Center Hospital East Division for the Promotion of Drug and Diagnostic Development