Status:
COMPLETED
MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer
Lead Sponsor:
Xilis, Inc.
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to determine the feasibility of generating sufficient MicroOrganoSpheres (MOS) from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 18 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05189171
Start Date
October 25 2022
End Date
March 18 2024
Last Update
June 28 2024
Active Locations (7)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
MedStar Washington Hospital
Washington D.C., District of Columbia, United States, 20010
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Mayo Clinic
Rochester, Minnesota, United States, 55905