MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

Inclusion Criteria

• Subject signed a valid, Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form.
• Male or female age 18 or older when written informed consent is obtained.
• Study candidate is willing and able to comply with all protocol-required procedures and assessments.
• Study candidate either
• is scheduled for or plans to be scheduled for a biopsy of the liver OR
• has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver. Key

Exclusion Criteria

• If already scheduled for a biopsy of the liver: liver biopsy was ordered to help diagnose, determine the severity of, or treat a disease that is unrelated to colorectal cancer (e.g., nonalcoholic fatty liver disease, chronic hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, etc.).
• Study candidate is participating (or intends to participate) in another clinical study AND either:
• is currently receiving investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver as part of that study OR
• that study only allows investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver (simultaneous participation in a clinical trial standard of care control arm is allowed, provided the subject is either already randomized or may be randomized to the control arm).
• Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.