MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

Key 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.