IMPROVE: Circulating Tumor DNA Analysis to Optimize Treatment for Patients With Colorectal Cancer

Other illness

• Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• Malignant colorectal polyps diagnosed after polypectomy
• Synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma)
• Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening

Other

• Verified distant metastases
• Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
  • Part II: Surveillance:

• Colon or rectal cancer, clinical tumor stage I-III
• Patient able to understand and sign written informed consent
• Scheduled for curative intended resectional surgery
• One of the following:
• TNM stage III CRC,
• or TNM stage II CRC and risk factors qualifying for adjuvant chemotherapy,
• or TNM stage I or stage II CRC without risk factors, but ctDNA positive in the post-operative day14 plasma sample. Inclusion requires that the patient declined participation in the IMPROVE IT trial.

Criteria the registry did not label

• Part I: Surgery