Genetic Alterations and clinical record in radically resected colorectal cancer revealed by Liquid biopsy And whole eXome analYsis

UMIN ID: UMIN000039205

Registered date:20/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colon and Rectal cancer that can be treated radically
• Date of first enrollment: 2020/04/01
• Target sample size: 6300
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Observational

Outcome(s)

• Primary Outcome: All: Disease-free Survival Cohort D: Sensitivity and specificity of ctDNA for the presence of lymph node metastases in additional colorectal resections

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Two or more synchronous colorectal cancer (multiple cancer) * * In case of patients with stage II, III, IV or recurrent (M1) colorectal cancer according to the 8th edition of the UICC, patients with clinical stage Tis or T1a colorectal cancer judged to be cured by local treatment may be included in this study. * If patients with pT1 colorectal cancer after local resection (complete en bloc resection with negative margins), have other cancers up to clinical stage T1a that can be judged to be cured by local treatment, registration is possible only if it is confirmed that the cancer was radically resected by local treatment. (2) Active double cancer. (3) In case of enrolled in Cohort A or Cohort D, history of surgery, chemotherapy, immunotherapy, or radiotherapy within 6 months before enrollment. (4) Pregnant or breastfeeding women. (5) Serious complication. (6) Positive for HBs antigen or positive for HCV antibody*. *Patients who are positive for HCV antibody but negative for HCV-RNA is eligible. (7) HIV antibody positive (a patient may enroll even if HIV antibody has not been tested). (8) Active novel coronavirus infection (COVID-19) is present*. * Patients with positive SARS-CoV-2 PCR or suspected COVID-19 based on clinical symptoms; patients with confirmed negative SARS-CoV-2 PCR or other tests and no symptoms of COVID-19 may be include in this study. However, if the physician deem that the patients will affect the evaluation of this study, the patients are ineligible. (COVID-19 testing is not required). (9) The study doctor deemed that it is ineligible for this study.

Related Information

• Primary Sponsor: National Research and Development Agency, National Cancer Center
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development. National Research and Development Agency, National Cancer Center. Alpha-A Inc.